Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted b

FDA device recall Z-2204-2021 · posted 2021-08-06 · Terminated

Recall details

Recalling firm

BioMedical Equipment Service Co (BMES)

Reason for recall

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

Action taken

Recall notification emails were sent to customers beginning 2/25/21. The emails stated the following: We have been notified by the FDA and our distributor about a voluntary part recall, to address potential performance concerns for a bezel part used in the service and repair of Alaris Pump Module 8100. The bezel part subject to this corrective action was used in the service and repair of the Alaris Pump Module 8100 between July 10, 2020 and February 18, 2021. The part is from a distributor and is not a BMES part. We have switched distributors since learning of the issue. While it's listed as a voluntary recall we do not consider fixing the issue voluntary. BMES will cover the replacement of all impacted bezel repair parts under this field safety corrective action. A detailed letter is attached with the specifics outlined below. Formal Letter Customer Response Form Images of Impacted bezel repair part List of Impacted repairs. Our records indicate that BMES performed service and repair, including the installation of the impacted part on (X) out of a quantity of (Y) Alaris 8100 repairs. Next Steps REad through the attached letter and complete the attached form titled attachment A within the attached letter and email it to our BMES Quality Assurance, Jesse Curry at jcurry@bmesco.com. After placing the potentially affected pump in quarantine, please contact Quality Assurance at 1-800-626-4515 or email Jesse Curry at jcurry@bmesco.com to schedule replacement of the impacted part. The letter attached to the emails, titled "URGENT: Voluntary Field Safety Corrective Action Bezel Repair Part for Alaris Pump Module Model 8100" provided additional details regarding the product issue and the associated health risks.

Root cause

Component design/selection

Status

Terminated

Product code

FRN

Quantity affected

718 potentially affected pumps

Distribution

The affected products were distributed to the following US states: CA, IL, IN, KY, LA, NJ, NV, OH, and PA.

Date initiated

2021-02-25

Date posted

2021-08-06

Date terminated

2024-04-22

Location

Louisville, KY

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