BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3853388 · Received April 7, 2014

    Report

    Report Number
    2916596-2014-00526
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    February 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR REPORT #2916596-2014-00271 FOR THE INITIAL REPORT ON THE LVAD SERIAL NUMBER (B)(4). MANUFACTURER IS ATTEMPTING TO ACQUIRE THE SYSTEM CONTROLLER FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOG FILE DATA RETRIEVED FROM THE SYSTEM CONTROLLER REVEALED A PUMP STOPPAGE EVENT RECORDED, CONSISTENT WITH THE REPORTED EVENT. THE SUBSEQUENT EVENTS RECORDED IN THE LOG FILE INDICATED THAT THE PUMP RETURNED TO THE SET SPEED AND REMAINED THERE UNTIL THE SYSTEM CONTROLLER WAS REMOVED FROM CLINICAL USE. THE FUNCTIONAL TESTING PERFORMED ON THE RETURNED SYSTEM CONTROLLER USING THE EQUIPMENT IN OUR LAB FOUND THE DEVICE TO OPERATE AS INTENDED. THE EVENT RECORDED IN THE LOG FILE COULD NOT BE ATTRIBUTED TO THE RETURNED SYSTEM CONTROLLER AND A ROOT CAUSE FOR THE PUMP STOPPAGE EVENT COULD NOT CONCLUSIVELY BE DETERMINED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. PLEASE REFERENCE MFR REPORT # 2916596-2014-00271 FOR INFORMATION REGARDING THE SUSPICION OF THROMBUS AND EVALUATION OF THE EXPLANTED LVAD. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR INITIALLY REPORTED THAT THE PATIENT CAME TO THE HOSPITAL FOR LOW HEMOGLOBIN AND RECEIVED BLOOD. THE VAD COORDINATOR NOTICED A PUMP OFF ALARM IN THE PATIENT'S VAD HISTORY. THE PATIENT CLAIMED HE DID NOT HEAR ANY ALARMS AND DID NOT NOTICE THE DRIVELINE DISCONNECTED. THE VAD COORDINATOR ALSO NOTICED A LOW SPEED OPERATION ALARM. AN ECHOCARDIOGRAM (ECHO) REPORTEDLY CAME BACK SUSPICIOUS FOR A THROMBUS NEAR THE VAD INFLOW. AN EVENT LOG SUBMITTED TO THE MANUFACTURER'S TECHNICAL SERVICES GROUP FOR ANALYSIS CONFIRMED THE REPORTED ALARMS. APPROXIMATELY THREE WEEKS LATER IT WAS REPORTED THAT THE ALARMS HAD STOPPED AND THE PATIENT WAS DOING FINE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE VAD COORDINATOR ON (B)(6) 2014 STATING THAT THE HOSPITAL STAFF NOTICED IN THE SYSTEM CONTROLLER EVENT HISTORY THERE WERE LOW SPEED ADVISORIES FOLLOWED BY A "PUMP OFF" ALARM. THE TECHNICAL SERVICE GROUP REVIEWED THE EVENT LOG AND THE EVENTS APPEARED TO BE CONTINUING FROM THE PREVIOUS REPORTED EVENTS. THERE WERE LOW SPEED EVENTS ON BOTH BATTERY POWER AND WHEN CONNECTED TO THE POWER MODULE. IT WAS ALSO NOTED THAT THERE WERE PUMP STOPS WHILE CONNECTED TO BATTERY. THE PATIENT DID NOT HAVE ANY SYMPTOMS DURING THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209001 HEARTMATE II SYSTEM CONTROLLER DSQ:LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other