BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM HEART SYSTEM, DISPOSABLE TUBING

    MDR report key: 1845010 · Received September 22, 2010

    Report

    Report Number
    MW5017568
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 22, 2010
    Manufacturer
    CARDIAC ASSIST INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE TUBING CHANGE ON CARDIAC ASSIST TANDEM HEART DEVICE IS DONE EVERY 4 DAYS AT OUR INSTITUTION. DISPOSABLE TUBING SET TO CONTROLLER PRIMED, CONTROLLER SCREEN INSTRUCTIONS FOLLOWED. WHILE ATTEMPTING TO DISCONNECT OLD TUBING SET FROM THE PT'S SIDE, THE TUBING WOULD NOT DISCONNECT JUST BELOW THE BACTERIOSTATIC FILTER. I HAD MY CLAMP IN MY HAND, IN ORDER TO CLAMP THE TUBING IF ANYTHING ADVERSE OCCURRED. I TWISTED THE CLEAR, PLASTIC CONNECTION TO DISCONNECT, AND THE CLEAR PLASTIC TUBING FROM THE PT SIDE BROKE OFF JUST BELOW THE CLEAR PLASTIC CONNECTOR. IT DID NOT LOOSEN FROM THE BACTERIOSTATIC FILTER. RESULT WAS PERFUSIONIST AND SURGEON BEING SUMMONED ON A SUNDAY EVENING TO CHANGE THE PT-SIDE OF THE DEVICE AT BEDSIDE. PT IS FINE WITH NO ADVERSE EFFECTS. I HAVE SPOKEN WITH THE CHIEF PERFUSIONIST REGARDING THIS ISSUE, AND HE STATES THAT CONNECTION HAS ALWAYS BEEN DIFFICULT, AND THAT FLUID DYNAMICS CREATE A VACUUM THAT MAKES IT DIFFICULT TO DISCONNECT THE TUBING SET. DIAGNOSIS OR REASON FOR USE: CARDIOGENIC SHOCK, HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM HEART SYSTEM, DISPOSABLE TUBING TANDEM HEART DSQ CARDIAC ASSIST INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening