FDA MedWatch - Alaris Infusion Pump Module 8100 Bezel by Pacific Medical Group:

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 Pacific Medical Group: Class I Recall - Due to Possible Cracked or Separated Bezel Repair Posts AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Pacific Medical Group (DBA Avante Health Solutions) is recalling the affected products and devices because the front 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 patient over delivery or under delivery of fluids delivered to a patient interruption of fluids delivered to a patient There have been 62 complaints reported about this device issue and one death may have been related to this recall. No other injuries have been reported. 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 and recommendations to follow, 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 front bezel component is critical to the proper performance of the infusion pump. Bezel posts from Pacific Medical Group are used to service and repair infusion pump modules. RECOMMENDATIONS: On March 24, 2021, Pacific Medical Group (DBA Avante Health Solutions) sent a Medical Device Recall Notification to all affected customers. The letter requested that customers take the following actions: Identify if you have affected product. Remove affected devices from clinical use and immediately quarantine them until the impacted parts can be returned to Pacific Medical Group. 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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