BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VRV-11C VACUUM RELIEF VALVE

    MDR report key: 3523371 · Received December 2, 2013

    Report

    Report Number
    1649914-2013-00068
    Event Type
    Injury
    Date Received
    December 2, 2013
    Date of Event
    October 21, 2013
    Report Date
    November 5, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K760894
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE DEVICE DISTRIBUTOR REPORTED THAT A VACUUM RELIEF VALVE LEAKED DURING A PROCEDURE AT A DOMESTIC HOSPITAL. IT WAS REPORTED THAT THE ALLEGED EVENT OCCURRED WHILE THE PATIENT WAS ON BYPASS. THE CUSTOMER STATED THAT VENTING PROCEEDED WITHOUT PROBLEMS FOR ALMOST AN HOUR BEFORE THE VENT VALVE BEGAN TO LEAK BLOOD. THE INFORMATION PROVIDED INDICATED BLOOD LOSS OF APPROXIMATELY 50-100CC AS A RESULT OF THE ALLEGED EVENT. THE REPORT STATED THAT THE VALVE WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FURTHER COMPLICATIONS OR DELAYS REPORTED AND NO OTHER IMPACT TO THE PATIENT REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION DESPITE MULTIPLE REQUESTS FOR ITS RETURN. THE LOT NUMBER WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623202 VRV-11C VACUUM RELIEF VALVE SUCTION CNTROL, INTRACARDIAC, CARDIOBYPASS DWD QUEST MEDICAL, INC. 4004203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention