BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 20690539 · Received November 14, 2024

    Report

    Report Number
    2916596-2024-07286
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 30, 2024
    Report Date
    December 19, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULTS AND DAMAGE TO THE MODULAR CABLE (LOT NUMBER 6903885) WAS CONFIRMED VIA LOG FILE ANALYSIS AND EVALUATION OF THE RETURNED CABLE. THE MODULAR CABLE WAS RETURNED AND TESTED WITH THE EVENT SYSTEM CONTROLLER AND PASSED TESTING WITHOUT ISSUE OR ALARMS. THE DRIVELINE POWER FAULT ALARMS WERE NOT REPRODUCED DURING THIS TEST. THE MODULAR CABLE DID NOT PASS INSULATION TESTING, AND THE BROWN WIRE, RESPONSIBLE FOR THE POWER A LINE, WAS NOTED TO HAVE A RAISED RESISTANCE, ESPECIALLY WHEN MANIPULATED, INDICATING WIRE FATIGUE. SUSTAINED RAISED RESISTANCES IN THIS WIRE WOULD CAUSE A DRIVELINE POWER FAULT ALARM TO ACTIVATE. THE OUTER LAYERS WERE STRIPPED, AND IT WAS FOUND THAT THE UNDERLYING WIRES OF THE MODULAR CABLE WERE KINKED IN SEVERAL PLACES, AND THE BROWN WIRE WAS FOUND TO HAVE EXPOSED CONDUCTORS. WHEN THE DAMAGED AREAS WERE MANIPULATED WHILE CONNECTED TO THE SYSTEM CONTROLLER AND A MOCK CIRCULATORY LOOP, THE ALARMS WERE REPRODUCED. A REVIEW OF THE SUBMITTED AND DOWNLOADED LOG FILES FROM THE REPORTED EVENT DATE OF 30OCT2024 SHOWED A DRIVELINE POWER FAULT ALARM ACTIVATING AT 00:40 DUE TO INTERMITTENT FLUCTUATIONS OF THE POWER A SIGNAL BELOW THE ALARM THRESHOLD. THE DRIVELINE POWER FAULT ALARMS DID NOT PREVENT THE PUMP FROM OPERATING AT ITS SET SPEED, AND THE CONTROLLER WAS ABLE TO SUPPORT THE SYSTEM AS INTENDED WHILE THE DRIVELINE WAS CONNECTED. THE DRIVELINE WAS DISCONNECTED AT 12:25, CONSISTENT WITH THE REPORTED CONTROLLER AND MODULAR CABLE EXCHANGE. PROVIDED INFORMATION INDICATED THAT THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED AND THAT THE EXCHANGE RESOLVED THE ALARMS. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO DAMAGE TO THE MODULAR CABLE, BUT THE ROOT CAUSE OF THE MODULAR CABLE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND REVEALED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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 DRIVELINE FAULT ALARMS. HEARTMATE III INSTRUCTIONS FOR USE (REV. C) SECTION 2 - ¿SYSTEM OPERATIONS¿ AND HEARTMATE III PATIENT HANDBOOK (REV. D) SECTION 2 - ¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. 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. 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 DRIVELINE POWER FAULT ALARMS. THE PATIENT HAD VISIBLE DAMAGE TO THEIR MODULAR CABLE WITH PREVIOUSLY APPLIED RESCUE TAPE (CS-203792). THERE WAS NO VISIBLE DAMAGE TO THE SYSTEM CONTROLLER. IT WAS PLANNED THAT THE MODULAR CABLE AND SYSTEM CONTROLLER WERE GOING TO BE EXCHANGED. THE LOG FILES WERE REVIEWED AND CONFIRMED DRIVELINE POWER (A) FAULTS. THE PUMP APPEARED TO BE OPERATING WITHIN NORMAL PARAMETERS. IT WAS RECOMMENDED THAT A MODULAR CABLE AND SYSTEM CONTROLLER EXCHANGE BE PERFORMED. THE EQUIPMENT WAS EXCHANGED AND THE ALARM RESOLVED. PHOTOS WERE PROVIDED. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204296 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 6903885 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male