BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 14859145 · Received June 29, 2022

    Report

    Report Number
    2916596-2022-12006
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    April 1, 2022
    Report Date
    June 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF A DRIVELINE POWER FAULT ALARM WAS CONFIRMED VIA LOG FILE ANALYSIS. A REVIEW OF THE LOG FILES CONTAINED DATA SPANNING APPROXIMATELY 7 DAYS ((B)(6) 2022 ¿ (B)(6) 2022, AND (B)(6) 2022 PER TIMESTAMP). ON (B)(6) 2022 AT 12:30:02, 17:28:38, 17:31:32 AND (B)(6) 2022 AT 17:10:26, POWER A BROKEN FAULTS WERE CAPTURED. DRIVELINE POWER FAULT ALARMS, ASSOCIATED WITH THE POWER A BROKEN FAULTS, STARTED ON (B)(6) 2022 AT 17:10:28 DUE TO THE CURRENT SENSE ON LINE A DROPPING BELOW THE THRESHOLD AMPERAGE. THE ALARM DID NOT RESOLVE ITSELF IN THE LOG FILE. THE ALARM DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED LIMIT. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. HEARTMATE 3 VAD MODULAR CABLE (LOT # 183276) WAS RETURNED FOR ANALYSIS AND FUNCTIONALLY TESTED. THE MODULAR CABLE WAS TESTED WITH THE RETURNED SYSTEM CONTROLLER AND WAS FOUND TO OPERATE AS INTENDED DURING ANALYSIS. THE DRIVELINE POWER FAULT ALARM WAS UNABLE TO BE REPRODUCED THROUGHOUT ALL TESTING. THE CABLE¿S INTERNAL CONDUCTORS WERE TESTED AND FAILED DUE TO A WIRE MEASURING OUTSIDE THE RESISTANCE THRESHOLD. THE CABLE¿S POLYURETHANE AND INNER LAYERS WERE STRIPPED AND A KINK IN THE WIRE WAS OBSERVED. THE UNDERLYING BROWN, RED, AND BLACK WIRES WERE EXPOSED AND DAMAGED. A ROOT CAUSE OF THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE DUE TO POWER A, THE BROWN WIRE, BEING DAMAGED. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK SECTION 4 - ¿LIVING WITH THE HEARTMATE 3¿ AND SECTION 6 - ¿CARING FOR THE EQUIPMENT¿) INSTRUCTS USERS TO REGULARLY INSPECT THEIR MODULAR CABLES FOR SIGNS OF DAMAGE AND TO OBTAIN A REPLACEMENT IF NEEDED. DAMAGE TO THE MODULAR CABLE MAY INTERRUPT PUMP OPERATION. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 - ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 - ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE 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. 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 HAD DRIVELINE POWER FAULT ALARMS. THE PUMP WAS RUNNING FINE AND THE PATIENT WAS DOING WELL. A REVIEW OF THE LOG FILES BY TECHNICAL SERVICES FOUND INTERMITTENT DRIVELINE POWER FAULT ALARMS FROM (B)(6) 2022. THE PATIENT'S SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. THE DRIVELINE POWER FAULT ALARM HAD CLEARED AND HAD NOT RETURNED. THERE WAS NO ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923569 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 183276 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female