BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3042683 · Received April 9, 2013

    Report

    Report Number
    3007042319-2013-00055
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 11, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT IS IN ROUTE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO HEARTWARE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF HVAD® PUMP (B)(4) IN RELATION TO THE REPORTED EVENT. THIS INCLUDED CLINICAL EVALUATION, LOG REVIEW/ANALYSIS, VISUAL/FUNCTIONAL TESTING AND REVIEW OF MANUFACTURING DOCUMENTATION. THE REPORTED VAD STOP EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG ANALYSIS. HOWEVER, THE RETURNED CONTROLLER PASSED ALL FUNCTIONAL ANALYSIS. THE EVENT IS LIKELY RELATED TO THE BATTERY SWITCHING THAT WAS EXPERIENCED BY THE PATIENT WHEN HE ATTEMPTED TO REMOVE A DEPLETED BATTERY FROM HIS CONTROLLER (IN AN ATTEMPT TO REPLACE IT). IT APPEARS THAT THE REMAINING BATTERY DEPLETED EARLY DUE TO ONE OF ITS CELL PAIRS DROPPING BELOW THE 2.7 VOLT LIMIT, CAUSING THE FET TO OPEN AND SWITCH THE CONTROLLER TO THE OTHER NOW EMPTY PORT, CAUSING A LOSS OF POWER TO THE CONTROLLER, THEREFORE RESULTING IN THE VAD STOP. THE ROOT CAUSE OF THE BATTERY EARLY DEPLETION CANNOT BE CONCLUSIVELY DETERMINED. THE MOST LIKELY CAUSE ATTRIBUTED TO THIS EVENT IS THE THREE BATTERIES THAT FAILED DURING FUNCTIONAL ANALYSIS. FURTHERMORE, AN INTERNAL INVESTIGATION HAS BEEN OPENED UNDER (B)(4) IN ORDER TO ADDRESS THESE TYPES OF EVENTS. THIS IS ONE OF FOUR REPORTS (3007042319-2013-00055, 3007042319-2013-00124, 3007042319-2013-00125 AND 3007042319-2013-00126) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO REPORTED A VAD STOP ALARM APPROXIMATELY TWENTY-SEVEN MONTHS POST HEARTWARE LVAD IMPLANTATION. THE PATIENT WAS REPORTEDLY EXCHANGING A DEPLETED BATTERY FOR A CHARGED ONE AT THE TIME THE EVENT OCCURRED. THE BATTERY ON THE SECONDARY POWER PORT WAS REPORTED TO BE FULLY CHARGED AND WELL CONNECTED. THE PATIENT REPORTED FEELING DIZZY AT THE TIME OF THE VAD STOP BUT WAS ABLE TO ATTACH ANOTHER POWER SOURCE IMMEDIATELY. HE BELIEVES THAT THE VAD WAS STOPPED FOR APPROXIMATELY TEN SECONDS. HE COULD NOT REMEMBER WHICH BATTERY HAD BEEN FULLY CHARGED IN THE CONTROLLER POWER PORT OR WHICH CONTROLLER POWER PORT THAT BATTERY WAS LOCATED IN AT THE TIME OF THE EVENT. THE CONTROLLER AND BATTERIES WERE EXCHANGED AT THE HOSPITAL DURING HIS NEXT CLINICAL VISIT AS A PRECAUTIONARY MEASURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145929 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY - BAT004756| BATTERY - BAT006411| BATTERY - BAT004750| BATTERY - BAT004749