BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3915613 · Received June 11, 2014

    Report

    Report Number
    2916596-2014-00969
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENTS OF DRIVELINE DISCONNECT ALARMS AND PUMP STOPPAGE EVENT WERE CONFIRMED BASED ON THE LOG FILE ANALYSIS; HOWEVER, THE ALARM AND PUMP STOPPAGE COULD NOT BE REPRODUCED DURING TESTING OF THE RETURNED SYSTEM CONTROLLER. THE RETRIEVED LOG FILE DATA CAPTURED MULTIPLE DRIVELINE DISCONNECT ALARMS BETWEEN 05:50 AND 05:54 ON (B)(6) 2014, ACCORDING TO THE TIME STAMP. THE LOG FILE ALSO INDICATED THAT THE SYSTEM CONTROLLER WAS DISCONNECTED AND POWERED DOWN BEFORE BEING RECONNECTED AGAIN WITHIN ONE HOUR, CONSISTENT WITH REPORTED EVENT OF THE PATIENT SWITCHING FROM THE PRIMARY SYSTEM CONTROLLER TO THE BACKUP, THEN BACK TO THE PRIMARY SYSTEM CONTROLLER. THE SPECIFIC ROOT CAUSE FOR THE OBSERVED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED AS THE RETURNED SYSTEM CONTROLLER WAS FOUND TO FUNCTION AS DESIGNED DURING THE INVESTIGATION. THE PATIENT REMAINED ONGOING ON PUMP SUPPORT AT THE TIME OF THE EVENT. A REVIEW OF 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.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT CALLED AND STATED THAT DURING A DRESSING CHANGE, HIS SYSTEM CONTROLLER ALARMED "CONNECT DRIVELINE", BUT EVERYTHING WAS CONNECTED APPROX. THE PT AND HIS WIFE SUCCESSFULLY EXCHANGED THE SYSTEM CONTROLLER WITH THE PT'S BACKUP SYSTEM CONTROLLER BEFORE CALLING THE VAD COORDINATOR. WHILE SWITCHING FROM TETHERED SUPPORT (CONNECTED TO THE POWER MODULE) TO BATTERY POWER A "CONNECT POWER" ALARM OCCURRED. THE PT THEN CONNECTED TO THE POWER MODULE AND THE ALARM WENT AWAY. A FEW MINUTES LATER THE PT RETURNED TO BATTERY POWER AND THE "CONNECT POWER" ALARM OCCURRED AGAIN. THE PT THEN SWITCHED BACK TO HIS PRIMARY SYSTEM CONTROLLER. THE LOG FILE WAS SUBMITTED AND LOW SPEED AND PUMP STOPS WERE NOTED WHILE THE PT WAS CONNECTED TO THE POWER MODULE. THE PT PRESENTED TO THE CLINIC AND THE ALARM WAS CONFIRMED. THE ALARM WAS RESET AND THE EVENT HISTORY WAS ERASED. THE PT WAS ADMITTED INTO THE HOSPITAL AND X-RAYS WERE TAKEN. THE "CONNECT DRIVELINE" ALARM OCCURRED THAT EVENING. THE PT'S SYSTEM CONTROLLER WAS EXCHANGED WITH A NEW SYSTEM CONTROLLER. THE FOLLOWING DAY THE MANUFACTURER'S TECHNICAL SUPPORT ARRIVED ONSITE TO EVALUATE THE DRIVELINE, AND NO OPEN WIRES WERE FOUND. ALL WIRES TESTED TO HAVE CONTINUALLY. THE X-RAYS WERE REVIEWED AND THERE WAS NO INDICATION OF DAMAGE. THE SHIELDING OF THE DRIVELINE APPEARED TO HAVE CONTINUITY FROM THE PUMP END BEND RELIEF TO THE DISTAL END METAL CONNECTOR. NO FURTHER EVENTS OF LOW SPEED OR PUMP STOPS WERE NOTED SINCE THE SYSTEM CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343698 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other