BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARVIK 2000 LVAD

    MDR report key: 574439 · Received February 1, 2005

    Report

    Report Number
    574439
    Event Type
    Malfunction
    Date Received
    February 1, 2005
    Date of Event
    October 27, 2004
    Report Date
    February 1, 2005
    Manufacturer
    JARVIK HEART, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS STATUS POST IMPLANT OF JARVIK HEART, LEFT VENTRICULAR ASSIST DEVICE. THE PUMP ALARMED WITH MESSAGE "PUMP STOPPED". A CONTINUOUS ALARM TONE WAS SOUNDING AND ALL ALARM LIGHTS WERE FLASHING ON AND OFF, WHILE THE POWER INDICATOR CYCLED BETWEEN 3 AND 13. THE NURSES UNSUCCESSFULLY TRIED A FRESH BATTERY, THEN SWITCHED TO A BACK-UP CONTROLLER WHICH FAILED, SO THEY SWITCHED BACK TO THE ORIGINAL CONTROLLER AND CABLES. THEY UNSUCCESSFULLY ATTEMPTED TO DISCONNECT THE PATIENT LEAD FROM THE ABDOMINAL CABLE. THE INNER PORTION (WITH PINS) CAME FREE FROM THE OUTER PORTION OF A LOCKING LEMO CONNECTOR. THE PINS WERE SOMEWHAT BENT - ATTEMPTS WERE MADE TO STRAIGHTEN THE PINS. CONNECTOR WAS RE-INSERTED INTO CONTROLLER AND THE ALARM CONTINUED. TWO OR THREE MORE ATTEMPTS WERE MADE TO STRAIGHTEN THE PINS AND RE-PLUG. THIS DID NOT RESOLVE THE ALARM. AFTER THE ORIENTATION OF THE CONNECTION WAS CHECKED, PUMP RE-STARTED AFTER A QUARTER TURN. ONCE THE PUMP WAS RUNNING AGAIN, THE CONNECTOR WAS REBUILT WITH TAPE. THE THREADS INSIDE THE CONNECTOR HAD FRACTURED. THE LOWER HALF OF THE THREADS HAD TO BE REMOVED TO FIT THE PINS BACK INSIDE THE LEMO CONNECTOR. THIS WAS SECURED WITH ELECTRICAL TAPE, THEN WAS IT WAS TUBE HELD BY ZIP TIES. THE CONNECTOR BETWEEN THE PATIENT LEAD AND ABDOMINAL CABLE WAS SECURED WITH A SINGLE LOOP OF TAPE, AS IT WAS SOMEWHAT LOOSE. ABDOMINAL CABLE WAS LOOPED AND HELD IN A LOOP WITH ZIP TIES TO PREVENT STRESS ON THE CONNECTION. THE CONNECTION HAD LARGE AMOUNT OF OR PREP SOLUTION ON IT FROM ABDOMINAL SURGERY BUT NONE PENETRATED THE INNER PORTION OF THE LEADS, ON THE PATIENT CONNECTION OR THE ABDOMINAL CABLE. TOTAL TIME PUMP WAS OFF WAS BETWEEN 10-12 MINUTES AND THE PATIENT MAINTAINED RELATIVELY GOOD PULSE PRESSURE. THERE WAS NO HARM TO THE PATIENT. THE REPAIRED CONNECTOR SLIPPED SEVERAL DAYS LATER WITH A 10-15 SECOND INTERRUPTION OCCURRING. A COMPANY ENGINEER MADE A MORE PERMANENT REPAIR TO THE DRIVE LINE INCLUDING A METAL SLEEVED CONNECTOR. THE PATIENT WAS SUBSEQUENTLY TRANSPLANTED AND THE DEVICE REMOVED.

    Description of Event or Problem · 1

    THE PUMP AND DRIVELINE HAVE NOT BEEN RETURNED FOR A PHYSICIAL EVALUATION. THEY WILL BE RETURNED UNDER RIR # 545. REGARDING THE INTEGRITY OF THE LEMO DRIVE LINE CONNECTOR. HE INDICATED THAT IT IS POSSIBLE TO DAMAGE THIS PART OF THE PLASTIC CONNECTOR. HE INDICATED THAT CO RE-ENFORCED A PORTION OF THE LEMO CONNECTOR WITH A TITANIUM SLEEVE (CO 149, 10/01/04) FOR THE JHI-002 JARVIK 2000, (ABDOMINAL MODEL). THIS SHOULD REDUCE THE CHANCES OF BREAKAGE AT THAT POINT. SINCE THE FAILURE OF THE CONNECTOR WAS DUE TO EXCESS PHYSICAL DAMAGE CAUSED BY THE PT, AND THE CONNECTOR HAS BEEN RE-ENFORCED AT THE POINT WHERE BREAKAGE HAS BEEN OBSERVED, CO WILL CONTINUE TO MONITOR FOR THIS KIND OF FAILURE IN THE FIELD. A CORRECTIVE ACTION FOR THE PUMP (JKI-002) POWER CABLE REPAIR/REPLACEMENT IS PENDING (CA 37).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARVIK 2000 LVAD LVAD DSQ JARVIK HEART, INC. JHI-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR