BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 5691753 · Received June 1, 2016

    Report

    Report Number
    2916596-2016-01025
    Event Type
    Death
    Date Received
    June 1, 2016
    Date of Event
    May 1, 2016
    Report Date
    May 4, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT FOR THE BACKUP SYSTEM CONTROLLER REFERENCES THE PATIENT¿S ATTEMPTED EXCHANGE TO THE BACKUP SYSTEM CONTROLLER AND SUBSEQUENT EXPIRATION. THE BACKUP BATTERY FAULT ALARM WHICH OCCURRED ON THE PRIMARY SYSTEM CONTROLLER IS REPORTED UNDER MEDWATCH MFR REPORT # 2916596-2016-01024. DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE ¿ 2 YEARS AND 4 MONTHS. (CALCULATED FROM THE DATE OF MANUFACTURE). THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOR THE RETURNED SYSTEM CONTROLLER, SERIAL NUMBER: (B)(4). THE PATIENT'S BACKUP SYSTEM CONTROLLER WAS RETURNED FOR EVALUATION AND THE DATA LOG FILE WAS RETRIEVED FOR ANALYSIS. THE RETRIEVED LOG FILE CAPTURED MULTIPLE LOW FLOW HAZARD ALARMS ON (B)(6) 2016. THE RECORDED ACTUAL PUMP SPEED VALUES RANGED FROM 0-1630 RPM. THE RECORDED VOLTAGE VALUES SUGGEST THAT THE SYSTEM WAS CONNECTED TO EXTERNAL BATTERIES. THE FIRST EVENT CAPTURED ON THE BACKUP SYSTEM CONTROLLER WAS ON (B)(6) 2016 AT 06:16 PM. THE RETURNED BACKUP SYSTEM CONTROLLER WAS CONNECTED TO A TEST SYSTEM FOR EVALUATION. DURING THE EVALUATION, THE RETURNED SYSTEM CONTROLLER WAS UNABLE TO OPERATE A TEST PUMP. ONCE CONNECTED TO THE DRIVELINE, THE RETURNED SYSTEM CONTROLLER EXHIBITED PUMP OFF AND RED HEART ALARMS AND REMAINED IN THIS CONDITION FOR A FEW MINUTES. THE RETURNED SYSTEM CONTROLLER WAS THEN DISASSEMBLED AND FURTHER ANALYSIS REVEALED AN INTERNAL ISSUE WITH THE PRINTED CIRCUIT BOARD (PCB) WHICH COMPROMISED THE DRIVE CIRCUITRY. SIMILAR INCIDENCES HAVE WERE IDENTIFIED AND THE ISSUE HAS BEEN ADDRESSED VIA A CORRECTIVE AND PREVENTATIVE ACTION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACKUP BATTERY FAULT ALARM AT HOME AND ATTEMPTED TO EXCHANGE TO THEIR BACKUP SYSTEM CONTROLLER. REVIEW OF THE LOG FILE FROM THE BACKUP SYSTEM CONTROLLER BY THE MANUFACTURER'S TECHNICAL SERVICES REPRESENTATIVE REVEALED THE DRIVELINE WAS FIRST CONNECTED AT (B)(6) 2016 18:16. THE PUMP SPEED REACHED 1480 RPM BEFORE THE DRIVELINE WAS DISCONNECTED WITHIN THE SAME MINUTE. THE DRIVELINE WAS RECONNECTED AND DISCONNECTED WITHIN THE SAME MINUTE THREE ADDITIONAL TIMES, AT (B)(6) 2016 21:10, (B)(6) 2016 22:02, AND (B)(6) 2016 02:45. THE SPEED NEVER INCREASED ABOVE 1630 RPM. EXTERNAL BATTERIES WERE DISCONNECTED AT (B)(6) 2016 12:35 AND THE LAST EVENT RECORDED PRIOR TO LOSS OF ALL POWER TO THE SYSTEM CONTROLLER WAS AT (B)(6) 2016 19:31. IT WAS REPORTED THAT THE PATIENT PASSED OUT AND ULTIMATELY EXPIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345983 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death