BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUUM RELIEF VALVE IIC-CLEAR

    MDR report key: 717926 · Received May 16, 2006

    Report

    Report Number
    1649914-2006-00047
    Event Type
    Malfunction
    Date Received
    May 16, 2006
    Date of Event
    April 28, 2006
    Report Date
    May 5, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT# 25775.E09, ADDITIONAL EXP DATE: 01/30/2009.

    Description of Event or Problem · 1

    WHILE GIVING CARDIOPLEGIA, THE SURGEON NOTICED THAT THE HEART WAS NOT STOPPING. THE SURGEON REQUESTED INCREASED CARDIOPLEGIA AND THEN NOTICED BLOOD ON FLOOR. THE PERFUSIONIST CHECKED THE CIRCUIT AND NOTED BLOOD AROUND VALVE. THE VALVE WAS REPLACED AND NO FURTHER INCIDENTS WERE REPOATED. THE PRODUCT WAS SAVED AND WILL BE RETURNED. PRODUCT CODE 400103, LOT NUMBER IS EITHER 25259.C11 OR 25775.E09

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUUM RELIEF VALVE IIC-CLEAR VACUUM RELIEF VALVE MNJ QUEST MEDICAL, INC. 4004103 25259.C11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN