BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 5083258 · Received September 16, 2015

    Report

    Report Number
    2916596-2015-01712
    Event Type
    Death
    Date Received
    September 16, 2015
    Date of Event
    August 15, 2015
    Report Date
    August 19, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION. DEVICE UNIQUE IDENTIFIER (UDI) - DEVICE WAS MANUFACTURED PRIOR TO UDI LABELING IMPLEMENTATION. SYSTEM CONTROLLER (B)(4), THE PRIMARY SYSTEM CONTROLLER REPORTED TO BE IN USE AT THE TIME OF THE PATIENT'S EXPIRATION, WAS RETURNED FOR EVALUATION. THE DATA LOG FILE CONTAINED EVENTS STARTING ON DAY 0, 2 HOURS AND 25 MINUTES. THE DATA RECORDED AT DAY 0, 3 HOURS AND 47 MINUTES REVEALED THAT THERE WAS A DRIVELINE DISCONNECTED ALARM FOLLOWED BY A SPEED REDUCTION TO 0 RPM. THE INFORMATION RECORDED ONE MINUTE LATER INDICATED THAT THERE WAS A POWER CABLE DISCONNECT ALARM FOLLOWED BY A COMPLETE LOSS OF POWER. THE ASSOCIATED VOLTAGE LEVELS SUGGESTED THAT THE SYSTEM CONTROLLER WAS CONNECTED TO A POWER MODULE. SEVERAL POWER INTERRUPTIONS WERE RECORDED AFTER THE FIRST POWER RESET. THE DATA RECORDED AFTER THE LAST POWER RESTORATION INDICATED THAT THE SYSTEM CONTROLLER WAS CONNECTED TO 14V LI-ION BATTERIES FOR APPROXIMATELY 1 MINUTE AND THEN CONNECTED TO A POWER MODULE. THE SYSTEM OPERATED FOR 2 DAYS, 19 HOURS AND 51 MINUTES WHEN ANOTHER COMPLETE LOSS OF POWER WAS RECORDED. THE ASSOCIATED VOLTAGE LEVELS INDICATED THAT THE SYSTEM CONTROLLER WAS CONNECTED TO A POWER MODULE BEFORE THE POWER INTERRUPTION. AFTER THE POWER WAS RESTORED, THERE WERE THREE OTHER POWER INTERRUPTIONS RECORDED. SYSTEM CONTROLLER (B)(4) WAS FUNCTIONALLY TESTED AND WAS FOUND TO FUNCTION AS INTENDED, EVEN WHEN THE CABLES WERE MANIPULATED. THE WHITE AND BLACK POWER LEADS WERE INDEPENDENTLY DISCONNECTED, AND THE SYSTEM CONTINUED TO OPERATE PROPERLY. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE SYSTEM CONTROLLER PASSED ALL TEST STEPS. THE SYSTEM CONTROLLER OPERATED WHILE CONNECTED TO A MOCK CIRCULATORY LOOP AND NO ALARMS WERE NOTED. SYSTEM CONTROLLER (B)(4), WHICH WAS REPORTED TO BE THE PATIENT'S BACKUP SYSTEM CONTROLLER AT THE TIME OF THE EVENT, WAS RETURNED FOR EVALUATION. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND WAS FOUND TO FUNCTION AS INTENDED, EVEN WHEN THE CABLES WERE MANIPULATED. THE WHITE AND BLACK POWER LEADS WERE INDEPENDENTLY DISCONNECTED, AND THE SYSTEM CONTINUED TO OPERATE PROPERLY. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE CONTROLLER PASSED ALL TEST STEPS. THE SYSTEM CONTROLLER OPERATED WHILE CONNECTED TO A MOCK CIRCULATORY LOOP AND NO ALARMS WERE NOTED. THE DATA LOG FILE RETRIEVED FROM THE SYSTEM CONTROLLER CONTAINED 10 ENTRIES OF EVENTS INDICATING THAT THE SYSTEM CONTROLLER HAD NOT BEEN IN USE CONNECTED TO A PUMP. SYSTEM CONTROLLER (B)(4), WHICH WAS REPORTED TO BE THE BACKUP SYSTEM CONTROLLER REMOVED FROM THE PATIENT APPROXIMATELY ONE WEEK PRIOR TO THE EVENT, WAS RETURNED FOR EVALUATION. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED AND WAS FOUND TO FUNCTION AS INTENDED. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE SYSTEM CONTROLLER PASSED ALL TEST STEPS. THE SYSTEM CONTROLLER OPERATED WHILE CONNECTED TO A MOCK CIRCULATORY LOOP AND NO ALARMS WERE NOTED. THE DATA LOG FILE INDICATED THAT WHEN THE PUMP WAS CONNECTED TO THE SYSTEM CONTROLLER, THE SYSTEM OPERATED FOR APPROXIMATELY 5 MINUTES AT 9400 RPM AND THEN THE PERCUTANEOUS LEAD WAS DISCONNECTED. THE POWER RECORDED WHEN THE SYSTEM WAS OPERATING RANGED BETWEEN 5.9-6.1 WATTS, THE FLOW ESTIMATION WAS 4.5-4.7 LPM AND THE AVERAGE PULSATILITY INDEX WAS 4.7-5.4. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE ¿ 3 YEARS, 3 MONTHS. (CALCULATED FROM THE DATE WHEN THE SYSTEM CONTROLLER WAS ISSUED TO THE PATIENT). THE DEVICE WAS RETURNED FOR EVALUATION, HOWEVER, EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT AT THE TIME OF THE PATIENT'S DEATH THE PATIENT'S PRIMARY SYSTEM CONTROLLER WAS (B)(4), AND THE PATIENT'S BACKUP SYSTEM CONTROLLER WAS (B)(4). SYSTEM CONTROLLER (B)(4) WAS IN USE APPROXIMATELY ONE WEEK PRIOR TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2015 WITH INTERMITTENT RED HEART ALARMS. THE PATIENT WAS ASYMPTOMATIC AND HAD STABLE PUMP PARAMETERS AT THAT TIME. LOW FLOW AND PUMP STOPPAGE ALARMS WERE OBSERVED UPON REVIEW OF THE SYSTEM CONTROLLER HISTORY. THE PATIENT'S SYSTEM CONTROLLER WAS EXCHANGED AND THE PATIENT WAS SENT HOME. ON (B)(6) 2015, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEFIBRILLATOR SHOCK FOR VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION. BASED ON THE REPORT, THE NURSE PRACTITIONER CALLED 911 TO DISPATCH EMERGENCY MEDICAL SERVICES TO THE PATIENT'S HOME. UPON ARRIVAL, THE PATIENT WAS FOUND EXPIRED WITH THE DRIVELINE ATTACHED TO THE SYSTEM CONTROLLER WITH NO POWER SOURCE CONNECTED TO THE SYSTEM CONTROLLER. THE BATTERIES AND POWER MODULE PATIENT CABLE WERE FOUND NEARBY BUT NOT ATTACHED. LOG FILES WERE NOT OBTAINED FROM THE SYSTEM CONTROLLER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614184 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death