BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 14083683 · Received April 12, 2022

    Report

    Report Number
    2916596-2022-01910
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 19, 2022
    Report Date
    April 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

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A CONTROLLER FAULT WAS ABLE TO BE CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(4)) WAS RETURNED FOR ANALYSIS, AND LOG FILES WERE 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)2019, (B)(6) 2028, (B)(6) 2020, (B)(6) 2020, (B)(6) 2020, (B)(6) 2000, (B)(6) 2000 ¿ (B)(6)2000, (B)(6) 2022, AND (B)(6) 2022 PER TIMESTAMP). EVENTS CAPTURES ON (B)(6) 2022 TOOK PLACE IN THE TESTING LABS AT ABBOTT. EVENTS CAPTURED ON (B)(6) 2000 ¿ (B)(6) 2000 TOOK PLACE WHEN THE CLOCK WAS NOT SET; THEREFORE, THE EXACT DATED AND TIMES WERE UNABLE TO BE ACCURATELY RECORDED. THE DRIVELINE WAS CONNECTED ON (B)(6) 2000 AT 00:03:22. CONTROLLER FAULT ALARMS COINCIDENT WITH PWR_A_BROKEN AND OCP_A_OPEN (INTERNAL ERROR CODES: F4 AND F2) WERE ACTIVE ON01JAN2000 AT 14:10:33, CAUSING DRIVELINE POWER FAULTS TO BE ACTIVE FROM 01JAN2000 AT 14:10:33 THROUGH THE END OF THE LOG FILE AT 21MAR2022 AT 14:13:57. THE CLOCK WAS SET TO 21MAR2022 AT 07:04:00 DURING THE ALARMS. THE DRIVELINE WAS DISCONNECTED ON 21MAR2022 AT 11:48:15 AND THE CONTROLLER WAS SHUT DOWN AND PLACED INTO CHARGING MODE ON 21MAR2022 AT 11:48:57. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED WHILE THE DRIVELINE WAS CONNECTED. THE CONTROLLER WAS CONNECTED TO A SYSTEM MONITOR AND FUSE A (F6) WAS OPENED. THE FUSE WAS REPLACED AND THE CONTROLLER WAS RETESTED. THE CONTROLLER UNDERWENT PRELIMINARY AND FUNCTIONAL TESTING AND PASSED. THE CONTROLLER WAS ABLE TO OPERATE A MOCK LOOP AND FUNCTIONED AS INTENDED. THE ROOT CAUSE OF THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE CAUSED BY BROKEN WIRES IN THE ASSOCIATED MODULAR CABLE (LOT NUMBER: 190295) WHICH CAUSED A SHORT RESULTING IN THE FUSE A TO OPEN. HEARTMATE III INSTRUCTIONS FOR USE (REV. C) SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK (REV. C) 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. C) 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)(4)) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER ON 25FEB2020. 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 STARTED TO EXPERIENCE DRIVELINE POWER FAULT ALARMS ON (B)(6) 2022. A CONTROLLER EXCHANGED WAS DONE ON (B)(6) 2022 BUT THE ALARMS RECURRED. A MODULAR CABLE AND CONTROLLER EXCHANGE WERE DONE ON (B)(6) 2022. LOG FILES FROM THE CONTROLLER EXCHANGED ON (B)(6) 2022 CONFIRMED THE DRIVELINE POWER FAULTS AND NOTED THE POWER A FUSE IN THE CONTROLLER OPENED. THERE WAS NO INTERRUPTION IN PUMP SUPPORT DURING THESE EVENTS. REVIEW OF THE LOG FILES FROM THE CONTROLLER PLACED ON (B)(6) 2022 CAPTURED DRIVELINE POWER FAULTS ON (B)(6) 2022 AND ALSO SHOWED THE CONTROLLER'S POWER A FUSE WAS OPEN. LOG FILES AFTER THE SECOND CONTROLLER EXCHANGE SHOWED THE DRIVELINE POWER FAULT HAD NOT RETURNED AND THERE WERE NO CONTROLLER FUSE ISSUES. RELATED MANUFACTURER'S REPORT COVERING MODULAR CABLE: 2916596-2022-01909. RELATED MANUFACTURER'S REPORTS COVERING OTHER CONTROLLER: 2916596-2022-01908.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107348 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531US 7287074 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female