BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS 3ND DISPOSABLE

    MDR report key: 17079642 · Received June 6, 2023

    Report

    Report Number
    MW5118226
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 2, 2023
    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

    WHILE INFUSING THE PRODUCT, I REC'D AN MPS ERROR INDICATING "ARREST OCCLUSION DETECTED". I HAD TO DISCONNECT AND INFUSE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957151 MPS 3ND DISPOSABLE HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR QUEST MEDICAL INC. 67511

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male