BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUEST

    MDR report key: 1410840 · Received June 25, 2009

    Report

    Report Number
    MW5011746
    Event Type
    Malfunction
    Date Received
    June 25, 2009
    Date of Event
    June 11, 2009
    Report Date
    June 12, 2009
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    OET
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE QUEST DELIVERY SET LEAKED WHILE DELIVERY CARDIOPLEGIA TO A PATIENT. THE SET HAD TO BE CHANGED OUT WHILE ON CARDIOPULMONARY BYPASS. AFTER INSPECTION, THERE WAS A HOLE LOCATED ON THE UPPER SIDE OF THE LEFT BLADDER OF THE DELIVERY SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUEST MES DELIVERY SET OET QUEST MEDICAL, INC. 5001102-AS 34263A06

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other