BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5192366 · Received October 30, 2015

    Report

    Report Number
    3007042319-2015-02700
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 5, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. THEY ALSO OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER IN ORDER TO PREVENT DAMAGES. IT IS OUTLINED TO INSPECT THE POWER CONNECTIONS AND PINS ONCE A WEEK, ONE AT A TIME WHEN CHANGING THE POWER SOURCE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME WITH A WARNING TO SWITCH TO THE BACK-UP CONTROLLER IF THERE IS A CONTROLLER FAILURE THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ONE CONTROLLER (CON094642) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED THERE WAS AN ELECTRICAL FAULT ALARM ACCOMPANIED BY A VAD STOP, AS REPORTED. THESE APPEAR TO HAVE OCCURRED AS A RESULT OF THE CONTROLLER BEING DROPPED AND/OR GETTING WET, AND IS NOT AN INDICATION OF FAILURE OF THE DEVICE. ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS EITHER SHOCK TO THE DEVICE OR GETTING IT WET, AS DESCRIBED IN THE EVENT HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE THE PATIENT WAS IN THE "SHOWER AT HOME WHEN SHE DROPPED HER CONTROLLER AND STATES, IT MAY HAVE GOTTEN WET." IT WAS SAID THAT THE PATIENT EXPERIENCED AN ELECTRICAL FAULT, AND PUMP STOP AT THAT TIME, PATIENT DISCONNECTED AND RECONNECTED THE PUMP AND THE PUMP RESTARTED IMMEDIATELY. PATIENT HAD "NO SYMPTOMS AT THE TIME, AND TOLERATED THE PUMP TIME OFF WELL." THE PATIENT CALLED THE VAD COORDINATOR ON CALL AND WAS BROUGHT INTO THE CLINIC. IT WAS STATED THAT THE LOG FILES WERE SENT TO MANUFACTURER. THE LOG FILES SHOWED AN "ELECTRICAL FAULT AND PUMP STOP." THE COORDINATOR TRIED TO "REPRODUCE THE ALARMS, BY JIGGLING THE DRIVELINE, AND MOVING THE CONTROLLER AROUND, THE ALARMS WERE NOT REPRODUCIBLE." THE PATIENT WAS INSTRUCTED TO MONITOR FOR ANY "ADDITIONAL ALARMS, AND CARING FOR THE DRIVELINE WAS REVIEWED WITH HER, NO TWISTING BENDING, KINKING, ETC." NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721446 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR