BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS

    MDR report key: 1990014 · Received February 2, 2011

    Report

    Report Number
    1990014
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    CHEST TUBE AT 20CM SUCTION AT SHIFT CHANGE. ASSESSED SYSTEM A FEW TIMES DURING THE NIGHT AND ORANGE FLOATING DETECTION DEVICE WAS AT THE 20 CM MARK. NURSE WAS SITTING NEXT TO PATIENT'S BED AND, TWO HOURS LATER, NOTED THAT THE ORANGE FLOATING DETECTION DEVICE WAS ONLY HALF WAY INTO MONITORING SECTION INDICATING SUCTION WAS NOT AT 20 CM. THE SYSTEM WAS FOUND TO HAVE SELF SEALED OFF AT THE BLUE WATER SEAL OUTLET WHICH IS NORMALLY OPEN. IT ACTUALLY LOOKED LIKE IT HAD MELTED PRIOR TO PUNCTURE. SAME NURSE SET THIS UP THE DAY PRIOR AND IS 100% CONFIDENT THAT IT DID NOT LOOK ABNORMAL. SAME NURSE REPLACED THE OASIS CT CHEST TUBE DEVICE WITH A NEW ONE. WHILE AWAITING THE ARRIVAL OF DRAIN, HOLE WAS MADE IN CONNECTOR TO ALLOW SUCTION TO OCCUR.NIGHT LIGHTS WERE NOT ONLY LOW, DIM AND COOL, BUT WERE FAR AWAY FROM THE DEVICE. SURROUNDING LIGHT SHOULD NOT BE A CONTRIBUTING HEAT FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASIS DRY SUCTION WATER SEAL DRAIN CAC ATRIUM MEDICAL CORP 3600 SINGLE COLLECTION *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR