BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS 3 DISPOSABLE

    MDR report key: 20037825 · Received August 21, 2024

    Report

    Report Number
    MW5158706
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 14, 2024
    Report Date
    August 18, 2024
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MPS 3 DISPOSABLE REFERENCE 5163102 LOT 72479 HOLE IN VENT LINE DEVELOPED AFTER BEING PRIMED FOR 3 HOURS AT THE CONNECTION TO THE RESERVOIR. CUT THE DAMAGED TUBING OUT, ADDED A PERFUSION ADAPTOR TO THE LINE, AND RECONNECTED TO RESERVOIR. NO HARM TO PATIENT AND NO BLOOD LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363738 MPS 3 DISPOSABLE HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR QUEST MEDICAL, INC. 5163102 72429

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male