BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE MOBILE POWER UNIT

    MDR report key: 6134013 · Received November 29, 2016

    Report

    Report Number
    2916596-2016-02306
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 2, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT REPRESENTS THE REPORT THAT THE PATIENT CONNECTED THE MOBILE POWER UNIT (MPU) CORDS IMPROPERLY WHEN SWITCHING FROM BATTERY POWER TO MPU WALL POWER. THE MISCONNECTION TRIGGERED AN ALARM THAT LED TO THE PATIENT AND CAREGIVER ATTEMPTING TO TROUBLESHOOT THE EVENT. THE MPU IS AN APPROVED/COMMERCIALLY AVAILABLE DEVICE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE IS CURRENTLY UNDER IDE STUDY IN THE UNITED STATES. THE SUBSEQUENT TROUBLESHOOTING ACTIVITY BY THE PATIENT WHICH RESULTED IN A CONNECTION ISSUE AT THE HEARTMATE 3 DRIVELINE MODULAR CABLE THAT RESULTED IN A LOSS OF POWER TO THE LVAD IS REPORTED THROUGH THE IDE CLINICAL STUDY PROCESS. (B)(4). APPROXIMATE AGE OF DEVICE: 70 DAYS. (B)(4). NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT EXPECTED TO BE RETURNED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    MULTIPLE REQUESTS FOR PRODUCT RETURN WERE MADE; HOWEVER, THE MOBILE POWER UNIT (MPU) WAS NOT RETURNED FOR EVALUATION. THE INFORMATION PROVIDED BY THE CENTER INDICATED THAT THE PATIENT RECEIVED A LOW POWER ALARM WHILE CONNECTED TO THE MPU. REVIEW OF THE DOWNLOADED AND SUBMITTED SYSTEM CONTROLLER LOG FILES SUGGESTED THAT THE SYSTEM CONTROLLER WAS INCORRECTLY CONNECTED TO THE MPU. THE RECORDED POWER LEVELS WERE LOWER THAN EXPECTED AND IT CAUSED LOW POWER ADVISORY AND LOW POWER HAZARD ALARMS. THE INVESTIGATION OF THE RETURNED SYSTEM CONTROLLERS INDICATED THAT THE DRIVELINE WAS ALSO INCORRECTLY INSERTED INTO BOTH SYSTEM CONTROLLERS DURING THE ATTEMPTED EXCHANGES. ALTHOUGH THE MPU WAS NOT RETURNED FOR ANALYSIS, SIMILAR EVENTS HAVE BEEN IDENTIFIED AND A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING 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 (LVAD). IT WAS REPORTED BY THE PATIENT AND CAREGIVER THAT APPROXIMATELY 5 MINUTES AFTER CHANGING FROM BATTERY POWER TO THE MOBILE POWER UNIT, A LOW POWER ADVISORY ALARM OCCURRED. THEY HAD ATTEMPTED TO TROUBLESHOOT THE ALARM ON THEIR OWN, BUT THEN AT 8:36PM ON (B)(6) 2016 THEY CALLED THE IMPLANTING CENTER'S ON-CALL SERVICE FOR ASSISTANCE. IT WAS REPORTED THAT THE LVAD WAS RUNNING AT THAT TIME. A PHYSICIAN WENT TO THE PATIENT'S HOME TO TROUBLESHOOT THE SITUATION, AND REPORTED THAT A YELLOW WRENCH ALARM WITH A CALL HOSPITAL CONTACT MESSAGE WAS ACTIVE ON THE SYSTEM CONTROLLER; HOWEVER, THE PUMP RUNNING SYMBOL WAS NOT ILLUMINATED. EMERGENCY MEDICAL SERVICES WAS CALLED TO THE HOME. THE SYSTEM CONTROLLER WAS EXCHANGED BUT THE PUMP RUNNING SYMBOL STILL DID NOT ILLUMINATE, AND THE NEW SYSTEM CONTROLLER DISPLAYED ¿CHARGING¿. THE PHYSICIAN AND ON-CALL VAD COORDINATOR PERFORMED TROUBLESHOOTING OF ALL THE CONNECTIONS. IT WAS REPORTED THAT THE DRIVELINE MODULAR CABLE SHOWED AN EXPOSED YELLOW LINE AT THE CONNECTION; ATTEMPTS TO REINFORCE THE CONNECTION WERE REPORTED TO BE WITHOUT SUCCESS. THE PATIENT REPORTEDLY HAD BEEN UNCONSCIOUS FOR AN UNSPECIFIED AMOUNT OF TIME, AND AUSCULTATION CONFIRMED THAT THE PUMP WAS NOT RUNNING. ADVANCED CARDIAC LIFE SUPPORT (ACLS) MEASURES WERE PERFORMED AND THE PATIENT WAS TRANSPORTED TO THE IMPLANTING CENTER. IT WAS REPORTED THAT THE PATIENT EXPIRED. A USER FACILITY MEDWATCH REPORT WAS RECEIVED ON 11/28/2016 THAT STATED: THE PATIENT WAS ATTEMPTING TO CHANGE HIS LVAD FROM BATTERY POWER TO WALL POWER. IN DOING SO, THE PATIENT CONNECTED THE CORDS IMPROPERLY, TRIGGERING AN ALARM. THE PATIENT¿S ATTEMPTS TO TROUBLESHOOT THE PROBLEM (WHICH WERE MADE WITHOUT CALLING THE VAD TEAM) RESULTED IN LOSS OF POWER TO THE VAD, ULTIMATELY LEADING TO CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782430 HEARTMATE MOBILE POWER UNIT LVAD MOBILE POWER UNIT DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death POCKET CONTROLLERS (B)(4)