BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRV -11 (STERILE)

    MDR report key: 458085 · Received May 1, 2003

    Report

    Report Number
    1649914-2003-00027
    Event Type
    Malfunction
    Date Received
    May 1, 2003
    Date of Event
    March 24, 2003
    Report Date
    May 1, 2003
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE CABG CASE, THE VRVII WAS BEING USED WITHOUT ANY COMPLICATIONS. AT THE END OF THE CASE, THE PERFUSIONIST NOTICED A BLOOD LEAK BETWEEN THE HOOD + BODY OF THE VRV. THE LEAK DID NOT OCCUR DURING CARDIOPLEGIA DELIVERY. LEAKING WAS MINIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VRV -11 (STERILE) VACUUM RELIEF VALVE MNJ QUEST MEDICAL, INC. 4003103 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN