BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4957713 · Received July 31, 2015

    Report

    Report Number
    3007042319-2015-01739
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    April 14, 2015
    Report Date
    July 1, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THE MOST LIKELY ROOT CAUSE OF THE FAILURE IS AN IMPROPER RESISTIVE WELDING CONNECTION, WHICH LIKELY CONTRIBUTED TO THE EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS RECEIVED BY THE MANUFACTURER ON (B)(6) 2015. THE BATTERY WAS TESTED AND PASSED EXTERNAL VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING. THE BATTERY HAS BEEN RENDERED INOPERABLE BY THE PUV AND CUV FLAGS. FURTHERMORE, DURING INTERNAL REVIEW OF THE BATTERY FOUND THE PTC1 LTP340F TYCO RAYCHEM POLY SWITCH FUSE ASSEMBLY RESISTIVE WELDING CONNECTION BETWEEN CELL PAIR #4 AND CELL PAIR #3 WAS FOUND LIFTED - OPEN AND MAKING INTERMITTENT CONNECTION WITH CELL PAIR #3. AS A CONSEQUENCE OF THIS MALFUNCTION IS A RESULT OF IMPROPER RESISTIVE WELDING CONNECTION UNTO CELL PAIR #3. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. AS A RESULT THE BATTERY FAILED TO PERFORM AS PER SPECIFICATION. THE HEARTWARE VAD 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, INCLUDING TRANSPORTATION. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A SPARE SET OF FULLY CHARGED BATTERIES AVAILABLE AT ALL TIMES, BEYOND THE TWO (2) POWER SOURCES THAT ARE CURRENTLY CONNECTED TO THE CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY SHOWED A RED LIGHT WHEN CONNECTED TO THE CHARGER. THE BATTERY WAS EXCHANGED WITH NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500253 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1