CareFusion 303 Recalls

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

Hazard: 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.

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

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

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

Hazard: 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, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.

Hazard: 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.

Hazard: 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.

Hazard: 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 Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.

Hazard: 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 likelihood of patients experiencing delays in receiving medications.

Hazard: 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 medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed

Hazard: 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 wrong dose of medication that could lead to patient harm.

Hazard: 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 access to medications or supplies needed in residential or procedural care facilities.

Hazard: 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 medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay

Hazard: 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 populations.

Hazard: 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-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

Hazard: 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-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.

Hazard: 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.

Hazard: Infusion pump component defect may result in interruption of patient monitoring

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

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

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

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

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

Hazard: 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 patient therapy or monitoring.

Hazard: 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 patient therapy or monitoring.

Hazard: 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 delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.

Hazard: 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 interruption of therapy or monitoring.

Hazard: 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 interruption of therapy or monitoring.

Hazard: 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 interruption of therapy or monitoring.