BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGE CARDIOVASCULAR

    MDR report key: 23004086 · Received September 9, 2025

    Report

    Report Number
    3017540705-2025-00003
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 8, 2025
    Manufacturer
    MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR
    Product Code
    DWF
    UDI-DI
    00817278010347
    PMA / PMN Number
    K964200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED OVER PRESSURIZING FREE FLOW WITH A MULTIPLE PERFUSION SET PRIOR TO USE. NO INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915159 SURGE CARDIOVASCULAR MULTIPLE PERFUSION SET DWF MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR PER-1400S 09033-022425 00817278010347

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown