BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE

    MDR report key: 7375580 · Received March 27, 2018

    Report

    Report Number
    2916596-2018-01110
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    February 22, 2016
    Report Date
    March 27, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    FA-Q217-MCS-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE - 41 DAYS THE EVENT OCCURRED AT (B)(6). THE REPORT OF DRIVELINE COMMUNICATION FAULT ALARMS WAS CONFIRMED DURING THE EVALUATION OF THE PUMP. THE PUMP WAS RETURNED WITH THE PUMP CABLE CUT APPROXIMATELY 16.5 INCHES FROM THE HOUSING AND THE SEVERED PORTION WAS NOT RETURNED. EXAMINATION OF THE PUMP BLOOD-CONTACTING SURFACES FOUND NO ADHERED DEPOSITIONS OR THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A DEVICE RELATED ISSUE. THE POTTED AREA OF THE MOTOR APPEARED UNREMARKABLE AND NO ISSUES WERE NOTED WITH THE UNDERLYING ELECTRICAL CONTACTS. ELECTRICAL CONTINUITY TESTING OF THE PUMP CABLE CONFIRMED A SHORT BETWEEN THE YELLOW WIRE (COM B) AND GROUND (GND). THE LOG FILES RETRIEVED FROM THE PUMP SHOWED THE PUMP OPERATING AS INTENDED AT THE SET SPEED BETWEEN (B)(6) 2016 AND (B)(6) 2016. A DRIVELINE COMMUNICATION FAULT ASSOCIATED WITH COM B WAS ACTIVE FOR THE DURATION OF THIS TIME. THE ELECTRICAL SHORT BETWEEN COM B AND GND DID NOT APPEAR TO HAVE RESULTED IN A FUNCTIONAL ISSUE BUT WOULD HAVE CONTRIBUTED TO THE DRIVELINE COMMUNICATION FAULT CAPTURED ON THE LOG FILE. THE PUMP MOTOR WAS CUT OPEN AND FORWARDED TO ANOTHER FACILITY FOR FURTHER ANALYSIS. ADDITIONAL INVESTIGATION DETECTED A SHORT BETWEEN THE GREEN WIRE (COM A) AND GND. THE INVESTIGATION WAS UNABLE TO LOCATE THE CONDUCTIVE PATH OF THE COM A TO GND SHORT INSIDE THE PUMP. THE COM B SHORT AND INTERMITTENT COM A SHORT WOULD HAVE CONTRIBUTED TO THE INTERMITTENT PUMP PARAMETER DISPLAY ISSUES REPORTED IN (B)(6) 2016 AND (B)(6) 2016. A CAPA WAS OPENED TO FURTHER INVESTIGATION DRIVELINE COMMUNICATION FAULT EVENTS AND A FIELD NOTIFICATION HAS BEEN IMPLEMENTED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED A DRIVELINE COMMUNICATION FAULT ALARM OCCURRED ON (B)(6) 2016. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARM INSTANTLY CAME ON AGAIN. THE NEXT MORNING, THE PATIENT PRESENTED TO THE CLINIC WHERE THE ALARM WAS CLEARED; HOWEVER, THE ALARM RETURNED INSTANTLY. THE MODULAR CABLE AND THE SYSTEM CONTROLLER WERE THEN EXCHANGED AGAIN, AND THE ALARM CAME BACK INSTANTLY. REPORTEDLY, SOME MOISTURE WAS OBSERVED BETWEEN THE CLEAR SILICON RELIEF CUFF TO THE DRIVELINE CONNECTOR. ALL PUMP PARAMETERS WERE NORMAL. THE ALARM WAS SILENCED FROM THE SYSTEM MONITOR. X-RAY IMAGES REVEALED NO DAMAGE TO THE PORTION OF THE DRIVELINE INTERNAL TO THE PATIENT. IT WAS REPORTED THAT SUBSEQUENTLY, THE SYSTEM CONTROLLER HAD TEMPORARY BEEN UNABLE TO COMMUNICATE COMMUNICATION DISPLAYED DATA. THE PATIENT REMAINED ASYMPTOMATIC WITH THE DRIVELINE COMMUNICATION FAULT ALARM PERMANENTLY SILENCED. THE PATIENT SUBSEQUENTLY UNDERWENT A ROUTINE HEART TRANSPLANT ON (B)(6) 2016. DURING THE MANUFACTURER''S INVESTIGATION OF THE RETURNED PUMP, INTERMITTENT DUAL COMMUNICATION FAULT EVENTS WERE CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217565 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR