Medical News and Alerts

Alaris Infusion Pump Module 8100 Bezel

August 25, 2021

OPIC: Alaris Infusion Pump Module 8100 Bezel by Bio-Medical Equipment Service: Class I Recall – Due to Possible Cracked or Separated Bezel Repair Posts

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: Bio-Medical Equipment Service Co. 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, it 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 Bio-Medical Equipment Service Co. are used to service and repair infusion pump modules.

RECOMMENDATIONS: On February 25, 2021, Bio-Medical Equipment Service Co. sent a recall notification letter via email. 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.
  • Complete and return the customer response form.
  • Contact Bio-Medical Equipment Service Co. to schedule bezel repair part replacement. The impacted bezel repair part must be replaced before the pump can be returned to service.

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.
Read Recall Button

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