FDA MedWatch - Alaris Infusion Pump Module 8100 Bezel by Infusion Pump Repair:

Class I Recall - Due to Possible Cracked or Separated Bezel Repair Posts

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Alaris Infusion Pump Module 8100 Bezel by Infusion Pump Repair: Class I Recall - Due to Possible Cracked or Separated Bezel Repair Posts AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Infusion Pump Repair is recalling the affected products and devices because the bezel components may crack or separate, leading to inaccurate delivery of fluids to patients. The separation of one or more bezel posts may result in: free flow of fluids to a patient over delivery or under delivery of fluids delivered to a patient interruption of fluids delivered to a patient If this device issue occurs, this could cause serious patient harm. There have been no deaths, complaints or injuries reported for this recall. This recall is related to Tenacore's recent recall of the Alaris pump bezel assembly and Alaris infusion pumps repaired with the bezel assembly. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Alaris Infusion Pump Module Model 8100 is used to deliver fluids such as medications, nutrients, blood, and other therapies into a person's body, in controlled amounts. The bezel component is critical to the proper performance of the infusion pump. Bezels from Infusion Pump Repair are used to service and repair infusion pump modules. RECOMMENDATIONS: On March 24, 2021, Infusion Pump Repair sent a recall notification letter. Similar to the Tenacore recall notification, the letter requested that customers: Review the serial number list of pumps that are potentially impacted by the recall. Immediately quarantine the potentially affected devices. Inspect the potentially affected devices to determine if the impacted bezel repair part is installed. Contact Infusion Pump Repair to schedule bezel repair part replacement. The impacted bezel repair part must be replaced before the pump can be returned to service Complete and return the Customer Response Form 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.

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