FDA MedWatch - BD Alaris Pump Module Model 8100 by CareFusion 303:

Class I Recall - Due to Risk of Stuck or Unresponsive Keys

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: BD Alaris Pump Module Model 8100 by CareFusion 303: Class I Recall - Due to Risk of Stuck or Unresponsive Keys AUDIENCE: Patient, Health Professional, Risk Manager, Biomedical Engineering ISSUE: CareFusion 303 is recalling the Alaris Pump Module because of the risk of the keypad lifting up due to fluid entry. This could lead to keys that become unresponsive or stuck. This 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. Please note, this recall is separate from the BD Alaris Pump Module 8100 keypad recall dated August 4, 2020. For more information and detailed recommendations about this recall, click on the red button "Read Recall" below. BACKGROUND: 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 health care facilities. RECOMMENDATIONS: On March 3, 2021, CareFusion 303 sent a New Urgent Medical Device Recall letter to all affected customers and provided the following instructions:  For 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. For 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. For 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: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to edwardlorilla1986.paxforex@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA