CareFusion 303, INC

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing store…

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting…

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualif…

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

Antivirus software was not consistently installed on impacted devices during the implementation process.

During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access …

Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be …

Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot…

Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may res…

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devi…

Due to fingerprint scanner failing resulting in the scanner heating up.

Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.

Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunct…

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may l…

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.

Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to le…

If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the di…

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.

Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.

If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorre…

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwr…

After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.

Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.

Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server conne…

Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contr…

Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.

Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likel…

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling…

Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medicat…

Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or…

The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop functioning (Matrix drawers will stop opening in the MedBank Application) leading to delay in acce…

Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medicat…

Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient popu…

The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-s…

The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

Infusion pump component defect may result in interruption of patient monitoring

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an …

If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patie…

Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from…

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion…

Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2

Complaints where users were unable to prime the administration set.

The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or mo…

The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.

Reports of incorrect priming volume due to manufacturing with incorrect tubing.

The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.

Punctures in blister packaging that was detected during the packaging process.

There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.

BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.

CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.

CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.

During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.

CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusate…

Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.

A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.

A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.

The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.

CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product.

CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2.

CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.

CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.

Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.

An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.

CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.

CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that th…

CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.

Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect fro…

CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.

CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.

CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended.

CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead…

CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.

CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.

CareFusion is recalling the SmartSite® Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this…

The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010…

The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly

The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error…