BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSURE DISPLAY SET

    MDR report key: 30209 · Received February 14, 1996

    Report

    Report Number
    MW1008330
    Event Type
    Injury
    Date Received
    February 14, 1996
    Date of Event
    January 28, 1996
    Report Date
    February 13, 1996
    Manufacturer
    DLP, INC
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT MALFUNCTIONED 2 TIMES IN A 24-HOUR PERIOD; SAME LOT NUMBER. MEMBRANE BURST ON BOTH. "THE FIRST EVENT OCCURRED DURING A ROUTINE CHECK OF THE CIRCUIT. THE PRESSURE TRANSDUCER WAS NOTED TO BE BULGING AWAY FROM THE ACTUAL DISPLAY BOX AND WHEN THE RN WENT TO TIGHTEN THE TRANSDUCER BLEW APART AND BLOOD STARTED BACKING OUT OF THE CIRCUIT UNTIL SHE COULD GET TO THE STOPCOCK AND TURN IT OFF FROM WHERE IT WAS CONNECTED TO THE OXYGENATOR. THE SILICONE PART OF THE TRANSDUCER WHICH ACTUALLY CONNECTS TO THE PRESSURE BOX JUST EXPLODED INTO LOTS OF LITTLE PIECES AND, OF COURSE, WHEN THAT HAPPENS, YOU HAVE AN OPEN LINE FROM THE CIRCUIT TO THE OUTSIDE WHERE BLOOD LOSS OCCURS AND THIS IS WHAT HAPPENED. APPROX 24 HRS LATER, THE SAME EVENT OCURRED AGAIN DURING A ROUTINE CHECK. THE SPECIALIST NOTED THAT THE TRANSDUCER WAS BULGING FROM THE SILICONE PART AWAY FROM THE PRESSURE BOX AND WENT TO PUT HIS HANDS ON IT SO HE COULD CHECK IT TO SEE IF IT WAS SECURELY TIGHTENED, AND THE SILICONE PART OF THIS TRANSDUCER ALSO BLEW APART INTO MANY PIECES, AGAIN LEAVING AN OPEN CONNECTION FROM THE CIRCUIT TO THE OUTSIDE WHERE BLOOD CAME OUT. RPTR DID CONTACT THE MFR TO REPORT THESE INCIDENTS O THEM, AND THEY HAVE ALREADY SENT TWO NEW PRESSURE BOXES AND WILL BE PICKING RPTR'S UP TO CHECK THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE DISPLAY SET PRESSURE DISPLAY SET DRS DLP, INC 6951-2004

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention