BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 14496435 · Received May 25, 2022

    Report

    Report Number
    2916596-2022-10939
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    May 9, 2022
    Report Date
    September 12, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION THE REPORTED EVENT OF ATYPICAL ALARMS WAS ABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: HSC-060723) WAS RETURNED FOR ANALYSIS, AND A LOG FILE WAS SUBMITTED FOR REVIEW AND ANOTHER WAS DOWNLOADED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILES SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 10 DAYS (B)(6) 2022 ¿ (B)(6) 2022, (B)(6) 2022 ¿ (B)(6) 2022, (B)(6) 2022 - (B)(6) 2022, (B)(6) 2022 PER TIMESTAMP). ON 09MAY2022 AT 05:14:21 THE CONTROLLER UNDERWENT AN ABNORMAL RESET. THIS RESULTED IN THE LOG FILE UNABLE TO RECORD ANY INFORMATION ABOUT THE SYSTEM PARAMETERS. AFTER THE RESET, THE PUMP SPEED WAS RECORDED TO BE AT THE FIXED SPEED LIMIT INDICATING THAT THE PUMP OPERATION WAS NOT AFFECTED DURING THE RESET. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2022 AND THE CONTROLLER WAS SHUT OFF AT 09:44:38. THE DRIVELINE WAS NOT RECONNECTED FOR THE REMAINDER OF THE LOG FILE. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE SYSTEM CONTROLLER UNDERWENT PRELIMINARY AND FUNCTIONAL TESTING AND INITIALLY PASSED. THE SYSTEM CONTROLLER WAS CONNECTED TO A MOCK LOOP AND WAS ABLE TO OPERATE AS INTENDED WITH NO ALARMS ACTIVE. THE CONTROLLER UNDERWENT ADDITIONAL TESTING IN ORDER TO TRY AND REPRODUCE THE ALARMS. THE CONTROLLER WAS TESTED UNDER EXTREME CONDITIONS AND THE ALARMS WERE ABLE TO BE REPRODUCED FOR A SHORT DURATION. THE CONTROLLER UNDERWENT CIRCUIT ANALYSIS AND THE MICROCONTROLLER (U10) WAS FOUND TO BE THE ISSUE. THE COMPONENT WAS REPLACED AND ALL ISSUES WERE RESOLVED. NO FURTHER TESTING WAS CONDUCTED. THE ROOT CAUSE OF THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE CAUSED BY THE DAMAGED MICROCONTROLLER. HEARTMATE III INSTRUCTIONS FOR USE, REV. C, SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK, REV. D, SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING CONTROLLER FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE III INSTRUCTIONS FOR USE, REV. C, SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK, REV. D, SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER ON (B)(6) 2017. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD OCCASIONAL POWER CABLE DISCONNECT ALARMS WHILE ON BATTERY POWER. THE PATIENT INSPECTED AND CLEANED THE BATTERY CONTACTS AND BATTERY CLIPS, BUT INTERMITTENT BEEPING AND POWER CABLE DISCONNECT ALARMS WERE THEN NOTED WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU). THE PATIENT CAME IN TO THE CLINIC FOR EQUIPMENT INSPECTION. NO OBVIOUS DEFECTS TO THE POWER LEADS WERE FOUND AND THE ALARMS WERE NOT REPRODUCIBLE. THE PATIENT WAS PLACED ON THEIR BACKUP CONTROLLER FOR SAFETY. LOG FILES SUBMITTED FOR REVIEW SHOWED THAT POWER TO THE PUMP WAS BRIEFLY INTERRUPTED ON (B)(6) 2022. THE CONTROLLER EXCHANGE RESOLVED THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877239 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 6120827 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male