BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRV-II VACUUM RELIEF VALVE

    MDR report key: 7115404 · Received December 13, 2017

    Report

    Report Number
    1649914-2017-00108
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Report Date
    January 9, 2018
    Manufacturer
    QUEST MEDICAL, INC
    Product Code
    DWD
    PMA / PMN Number
    K760894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED INCIDENT. AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND IT FUNCTIONED AS INTENDED. LEAKING WAS OBSERVED FROM THE PRESSURE RELIEF VALVE UNDER THE HOOD AT APPROXIMATELY 11.91 PSI (615.92 MMHG) WHICH IS WITHIN THE ACCEPTABLE RANGE. THE DEVICE IS INTENDED TO RELIEVE PRESSURE AT NEGATIVE PRESSURE OF -150MMHG AND POSITIVE PRESSURE BUILDUP OF +340MMHG (AVG). A DHR REVIEW WAS CONDUCTED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    A REPORT RECEIVED STATES THAT THE VALVE LEAKED DURING BYPASS WITH 5ML BLOOD LOSS NOTICED AFTER THE CASE. THE VALVE WAS NOT CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY OR PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891574 VRV-II VACUUM RELIEF VALVE CPBP SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC 4004203 054016

    Patients

    Seq Age Sex Outcome Treatment
    1