BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 21394717 · Received February 18, 2025

    Report

    Report Number
    2916596-2025-01016
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 5, 2025
    Report Date
    May 2, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE POWER FAULT ALARM WAS CONFIRMED VIA REVIEW OF THE DOWNLOADED LOG FILE, AND EVALUATION OF THE RETURNED MODULAR CABLE (LOT NUMBER: 7880081) CONFIRMED DAMAGES THAT WOULD HAVE CONTRIBUTED TO THE EVENTS SEEN IN THE LOG FILE. THE EVENT LOG FILE FROM THE EXCHANGED CONTROLLER CONTAINED APPROXIMATELY ~2 DAYS OF RELEVANT INFORMATION (03FEB2025 TO 05FEB2025 PER TIMESTAMP). AT 9:47:01 ON 05FEB2025, A DRIVELINE POWER FAULT ALARM ACTIVATED DUE TO AN INTERNAL FAULT INDICATING THAT THERE WAS AN INTERRUPTION IN THE POWER A SIGNAL. THIS ALARM DID NOT IMPACT OPERATION OF THE PUMP. THE INTERNAL POWER A FAULT CLEARED WITHIN ~1 SECOND OF THE ALARM¿S ACTIVATION; HOWEVER, THE ALARM LATCHED AND REMAINED ACTIVE UNTIL THE SYSTEM CONTROLLER WAS EXCHANGED LATER THAT DAY. DURING FUNCTIONAL TESTING OF THE RETURNED MODULAR CABLE, A DRIVELINE POWER FAULT ALARM WAS ABLE TO BE REPRODUCED. ADDITIONAL TESTING INDICATED THAT THE INNER WIRES OF THE MODULAR CABLE WERE NOT ABLE TO PASS RESISTANCE AND INSULATION RESISTANCE TESTING REQUIREMENTS. WITH PHYSICAL MANIPULATION OF THE CABLE, THE BROWN (POWER A), RED (POWER B), AND ORANGE (GROUND B) WIRES WERE ELECTRICALLY SHORTING TO ONE ANOTHER. THE LAYERS OF THE MODULAR CABLE WERE REMOVED ONE AT A TIME, AND SEVERAL AREAS OF WIRE DAMAGES WERE IDENTIFIED. MOST NOTABLY WITHIN ~1 INCH OF THE SYSTEM CONTROLLER CONNECTOR BEND RELIEF, THE POWER A, POWER B, AND GROUND A WIRES WERE FOUND TO BE DAMAGED, EXPOSING THEIR INNER CONDUCTORS. THIS DAMAGE WAS DETERMINED TO BE THE ROOT CAUSE OF THE REPORTED EVENT, AS AN ELECTRICAL SHORT FROM THE POWER A SIGNAL TO THE GROUND SIGNAL WOULD HAVE CAUSED THE OBSERVED SIGNAL INTERRUPTIONS AND THE REPORTED ALARM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE III INSTRUCTIONS FOR USESECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING DRIVELINE POWER FAULT ALARMS. THE HEARTMATE III INSTRUCTIONS FOR USE - SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND THE HEARTMATE III PATIENT HANDBOOK- SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESS HOW TO STORE, MAINTAIN, AND CARE FOR ALL EQUIPMENT, INCLUDING THE MODULAR CABLE. DAMAGE TO THE MODULAR CABLE MAY RESULT IN AN INTERRUPTION OF PUMP OPERATION. 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.

    Additional Manufacturer Narrative · 0

    SECTION H6 (MEDICAL DEVICE PROBLEM CODE): CORRECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED A DRIVELINE POWER FAULT ON THEIR SYSTEM CONTROLLER AND NO OTHER ALARMS. THE SYSTEM CONTROLLER AND THE MODULAR CABLE WERE EXCHANGED WITHOUT INCIDENT. THE PRODUCTS WERE RETURNED TO ABBOTT FOR ANALYSIS. IT WAS ALSO SAID THAT THE SYSTEM CONTROLLER EXCHANGE RESOLVED THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168988 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7880081 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male