BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 14083653 · Received April 12, 2022

    Report

    Report Number
    2916596-2022-01909
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    March 19, 2022
    Report Date
    September 27, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    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 DRIVELINE POWER FAULTS WAS ABLE TO BE CONFIRMED. THE MODULAR CABLE (LOT NUMBER: 190295) WAS RETURNED FOR ANALYSIS, AND LOG FILES FROM THE ASSOCIATED HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(4)) WERE SUBMITTED FOR REVIEW AND ANOTHER WAS DOWNLOADED FOR REVIEW. A REVIEW OF THE SUBMITTED LOG FILES SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 8 DAYS ((B)(6)2022 ¿ (B)(6)2022, (B)(6)2022, AND (B)(6)2022 PER TIMESTAMP). EVENTS CAPTURES ON (B)(6)2022 TOOK PLACE IN THE TESTING LABS AT ABBOTT. CONTROLLER FAULT ALARMS COINCIDENT WITH VS_A_LOW WAS ACTIVE ON (B)(6)2022 AT 12:04:22 AND AT 12:04:23, THE FAULTS CHANGED TO PWR_A_BROKEN AND OCP_A_OPEN CAUSING DRIVELINE POWER FAULTS TO BE ACTIVE FROM (B)(6)2022 AT 12:04:22 AND CONTINUED THROUGH THE END OF THE LOG FILE. THE DRIVELINE WAS DISCONNECTED AT ON (B)(6)2022 FROM 20:49:42 ¿ 20:49:47 AND WAS RECONNECTED AT 20:49:50 AND WAS DISCONNECTED AGAIN AT 20:51:34. THE DRIVELINE WAS NOT CONNECTED AGAIN FOR THE REMAINDER OF THE LOG FILE. THE CONTROLLER WAS SHUT DOWN AND PLACED INTO CHARGING MODE ON (B)(6)2022 AT 20:52:06. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED WHILE THE DRIVELINE WAS CONNECTED. ADDITIONAL LOG FILES FROM THE ASSOCIATED HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(4)) 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 WERE ACTIVE ON (B)(6)2000 AT 14:10:33, CAUSING DRIVELINE POWER FAULTS TO BE ACTIVE FROM (B)(6)2000 AT 14:10:35 THROUGH THE END OF THE LOG FILE AT (B)(6)2022 AT 14:13:57. THE CLOCK WAS SET TO (B)(6)2022 AT 07:04:00 DURING THE ALARMS. THE DRIVELINE WAS DISCONNECTED ON (B)(6)2022 AT 11:48:15 AND THE CONTROLLER WAS SHUT DOWN AND PLACED INTO CHARGING MODE ON (B)(6)2022 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 MODULAR CABLE WAS CONNECTED TO THE MODULAR V4 TEST AND DID NOT PASS. THE MODULAR CABLE WAS ALSO CONNECTED AND FUNCTIONALLY TESTED WITH A TEST HEARTMATE 3 SYSTEM CONTROLLER IN THE LABS AT ABBOTT AND DRIVELINE FAULTS WERE ACTIVE; HOWEVER, THE MODULAR CABLE WAS STILL ABLE TO OPERATE A PUMP. THE MODULAR CABLE UNDERWENT CONTINUITY AND INSULATION TESTING AND DID NOT PASS. THE MODULAR CABLE WAS CUT TO INSPECT THE UNDERLYING LAYERS AND THE GREEN (COMM A), BLACK (GROUND A), AND BROWN (POWER A) WIRES WERE ALL BROKEN AND THE YELLOW WIRE (COMM B) WAS DAMAGED. THE BROWN AND BLACK WIRES WERE DAMAGED AT THE SAME POSITION CAUSING THE POWER A WIRE TO SHORT TO GROUND CAUSING THE FAULTS. MULTIPLE KINKS WERE ALSO FOUND THROUGHOUT THE CABLE. THE ROOT CAUSE OF THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE CAUSED BY BROKEN WIRES IN THE MODULAR CABLE. HEARTMATE III INSTRUCTIONS FOR USE ((B)(4)) SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK ((B)(4)) SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING DRIVELINE POWER FAULT AND CONTROLLER FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE III INSTRUCTIONS FOR USE (B)(4) ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK (B)(4) ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE AND ADVISES THE PATIENT NOT TO GET THEIR EQUIPMENT WET. HEARTMATE 3 LVAS IFU (REV. C) AND PATIENT HANDBOOK ((B)(4)) ARE CURRENTLY AVAILABLE. THE IFU AND PATIENT HANDBOOK CONTAINS INFORMATION ON CARING FOR THE DRIVELINE IN (B)(4) ¿LIVING WITH THE HEARTMATE 3". IN SEVERAL SECTIONS, THIS DOCUMENT WARNS THE USER TO NEVER PUT THE DRIVELINE, SYSTEM CONTROLLER, OR ANY EXTERNAL EQUIPMENT INTO WATER OR LIQUID; IMMERSION IN WATER OR LIQUID MAY CAUSE THE PUMP TO STOP. SECTION 4 "LIVING WITH THE HEARTMATE 3" OF THE PATIENT HANDBOOK (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. 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 FOR THE MODULAR CABLE (LOT NUMBER: 190295) WERE UNABLE TO BE REVIEWED DUE TO THE RECORDS BEING MAINTAINED BY THE VENDOR AND ARE UNAVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    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 REPORTS COVERING THE CONTROLLERS: 2916596-2022-01908, 2916596-2022-01910

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465075 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 190295 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female