FDA Class I Recall: BD Alaris Pump Module Model 8100 by CareFusion 303

April 19, 2021

CareFusion 303 is recalling the Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry, reported the FDA. This could lead to keys that become unresponsive or stuck or may lead to an infusion delay or interruption or prevent clinicians from changing fluid or medication infusions on the affected devices.

High-risk patient populations who are receiving life-sustaining infusions are at the greatest risk of harm. For these patients, delays or interruption of infusions can cause serious injury or death. There have been 79 complaints regarding this device issue. There are no reports of injuries or death.

This recall is separate from the BD Alaris Pump Module 8100 keypad recall dated Aug. 4, 2020. The BD Alaris Pump Module System is an infusion pump and vital signs monitoring system that consists of a PC Unit, the Guardrails Suite MX, and up to four removable infusion or monitoring modules (channels). The System is used to deliver fluids including medications, blood, or blood products, into a patient's body in a controlled manner. It is used in hospitals and other healthcare facilities.

The FDA recommends clinical users:

·        Remove the pump from service and send to your Biomedical Engineering staff if the Pump Module keypad shows signs of lifting, becomes unresponsive, or stuck.

·         Continue the infusion until it is safe to replace the PC Unit if you are administering a critical medication.

·         In an urgent situation, close the roller clamp on the IV administration set to stop an infusion.

The FDA recommends cleaning personnel:

·         Follow the cleaning instructions provided in the current Instructions for Use to minimize the potential for fluid entry during cleaning.

·         Do not use a cloth that drips. Wring out the cleaning cloth to squeeze out excess fluid.

·         Do not spray fluids directly onto the device.

·         Remove the pump from service and send to Biomedical Engineering if Pump Module keypad lifting or stuck or unresponsive keys are observed.

The FDA recommends biomedical engineering:

·         For Remediation of Pump Module Door Assembly Replacement Kits: Dispose of all Pump Module Door Assembly Replacement Kits dated from January 15, 2019 to November 14, 2019, according to facility guidelines.

·         For Remediation of Pump Module Keypads: Refer to "Attachment A" of the New Urgent Medical Device Recall letter for a list of affected serial numbers. Select one of the remediation options. Complete and return the Customer Response Form to acknowledge receipt of the notification and the recall instructions.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

FDA has the recall.