BEUDAMED
    FDA Recall Open, Classified

    Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set

    Recall: Z-2448-2024 · Initiated May 7, 2024

    Recall

    Recall Number
    Z-2448-2024
    Event Number
    94690
    Firm
    ICU Medical Inc
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 7, 2024
    Posted
    August 9, 2024
    Address
    600 N Field Dr, Lake Forest, IL, 60045-4835

    Description

    Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set

    Reason

    Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

    Action

    Consignees were notified on about 05/07/2024 via traceable mail with an "UPDATED URGENT MEDICAL DEVICE CORRECTION" letter to the original recall was expanding. Consignees were instructed to replace batteries the first time the pump issues a replace battery alarm. Continued use of pumps on battery after the first instance of the replace battery alarm will reduce the time from a low battery alarm to a depleted battery/infusion stopping. Additionally, pumps should be kept plugged into AC power, closely monitor if using battery power, have a backup pump available, and do not use a replacement battery with corroded battery terminals. Customers were also requested to ensure all users or potential users of these pumps are immediately made aware of this notification and proposed mitigations, and to complete and return the provided Response Form. For distributors, if the affected products have been potentially distributed, to immediately forward the notification to customers. For further inquiries, please contact ICU Medical using the following information: Global Complaint Management, 1-844-654-7780 (M-F, 8:00am 5:00pm CT) or [email protected] to report adverse events or product complaints; Technical Support 1-800-241-4002 (M-F, 8:00 am 6:00 pm CT) -additional information for technical assistance; or Field Corrections https://icumed.custhelp.com/app/market-action for Questions about this Field Correction Notice.

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.

    Quantity

    14,744 units