BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 4053373 · Received August 27, 2014

    Report

    Report Number
    2916596-2014-01457
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION THE REPORTED EVENT OF A SYSTEM CONTROLLER FAULT WAS CONFIRMED DURING ANALYSIS. THE SYSTEM CONTROLLER WAS CONNECTED TO A TEST PUMP AND DID NOT OPERATE THE TEST PUMP. FURTHER EVALUATION OF THE SYSTEM CONTROLLER¿S INTERNAL PRINTED CIRCUIT BOARD (PCB) REVEALED DAMAGED TRANSISTORS. MANIPULATION OF THE PCB ALLOWED A LOG FILE TO BE RETRIEVED SUCCESSFULLY. SEVERAL OCCURRENCES WERE NOTED THROUGHOUT THE LOG FILE, WHERE THE ACTUAL SPEED FELL BELOW THE LOW SPEED LIMIT WITH MULTIPLE MOTOR STOPPED EVENTS. DRIVELINE DISCONNECTED ALARMS WERE ACTIVE FOLLOWING THE MOTOR STOPPED EVENTS WHICH MAY HAVE BEEN CAUSED BY PHYSICAL DISCONNECTION BY THE PATIENT OR THE SYSTEM CONTROLLER'S RESPONSE DUE TO THE DRIVER CIRCUITRY DAMAGE. CAPTURED THROUGHOUT THE LOG FILE ARE MULTIPLE NO EXTERNAL POWER EVENTS CAUSED BY NO CONNECTION TO THE POWER MODULE OR BATTERIES RESULTING IN NO MEASURED VOLTAGES FROM THE BLACK AND WHITE POWER CABLES. WHEN NO EXTERNAL POWER EVENTS OCCUR, THE BACKUP BATTERY WOULD POWER THE SYSTEM CONTROLLER AND THE BACKUP BATTERY IN USE SIGNAL WOULD BECOME ACTIVE. IT WAS ALSO NOTED IN THE LOG FILE THAT DURING NO EXTERNAL POWER EVENTS, THE BACKUP BATTERY IN USE SIGNAL WOULD NOT BECOME ACTIVE. THIS WAS DETERMINED TO BE CAUSED BY THE BACKUP BATTERY NOT BEING FULLY INSTALLED. ALTHOUGH THE BACKUP BATTERY IN USE SIGNAL WAS NOT ACTIVE, THE SYSTEM CONTROLLER WAS STILL POWERED BY THE BACKUP BATTERY BECAUSE THE TIME CLOCK DID NOT RESET. SIMILAR EVENTS RELATED TO DAMAGED TRANSISTORS HAVE BEEN IDENTIFIED AND THE ISSUE WAS ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE AND PREVENTIVE ACTION PROCESS. THE RETURNED SYSTEM CONTROLLER WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS FOR THE RETURNED SYSTEM CONTROLLER. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THE SYSTEM CONTROLLER WAS ON BACK-UP BATTERY, THEN STATED IT NEEDED A CONTROLLER CHANGE, THEN COMPLETELY FAILED AND THE SCREEN WENT BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522992 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 134212

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR