Class 1 Device Recall Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES)

• Date Initiated by Firm: February 25, 2021
• Date Posted: August 06, 2021
• Recall Status: Terminated on April 22, 2024
• Recall Number: Z-2204-2021
• Recall Event ID: 88170
• 510(K)Number: K133532
• Product Classification: Pump, infusion - Product Code FRN
• Product: Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
• Code Information: Serial Numbers: 13414138 13414659 13414829 13415843 15221825 15221825 12744341 12835089 12861990 12875918 12959808 13077410 13077413 13077474 13681407 15306396 15306899 12420646 12421169 12635894 12781498 12949510 13367664 13415216 13931954 2000189 3000595 3000883 3060800 3114560 3163062 3169497 3704252 3704268 3704322 3704343 3704366 3704476 3704477 3704485 3704529 3704536 3704549 3704639 3704645 3704810 3704814 3704853 4109720 4110277 8000560 9885878 9923593 9923615 9923671 9923800 9928207 13900270 13895113 13895704 10938662 12335127 12356902 12357956 12371188 12377005 12377451 12377463 12377633 12377809 12377870 12378093 12378095 12378248 12378686 12379004 12435805 12447105 12447140 12447792 12447797 12447834 12447943 12457014 12527904 12534361 12558945 12559059 12560637 12569213 12609470 12609853 12610581 12610619 12610636 12610848 12611472 12612154 12612168 12612237 12612426 12612541 12612616 12612728 12612766 12613011 12613031 12613120 12613277 12613768 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• Recalling Firm/ Manufacturer: BioMedical Equipment Service Co (BMES); 2709 S Park Rd; Louisville KY 40219-3645
• For Additional Information Contact: Ed Evans; 502-361-4500
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN