BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 20216225 · Received September 13, 2024

    Report

    Report Number
    2916596-2024-06079
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 14, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 CONFIRMED VIA LOG FILE ANALYSIS. THE MODULAR CABLE (LOT NUMBER: 8830398) WAS RETURNED AND TESTED WITH THE EVENT SYSTEM CONTROLLER. THE MODULAR CABLE RETURNED WITH CORROSION ON SEVERAL OF THE IN-LINE CONNECTOR PINS DUE TO FLUID INGRESS. A REVIEW OF THE SUBMITTED AND DOWNLOADED LOG FILES SHOWED SEVERAL, INTERMITTENT DRIVELINE POWER FAULT ALARMS DUE TO INTERMITTENT INTERRUPTIONS TO THE POWER B SIGNAL. THE DRIVELINE POWER FAULT ALARMS DID NOT PREVENT THE PUMP FROM OPERATING AT ITS SET SPEED. THE DRIVELINE POWER FAULT ALARMS WERE NOT ABLE TO BE REPRODUCED WITH THE RETURNED CABLE AND CONTROLLER. THE MODULAR CABLE PASSED INSULATION TESTING, AND THE WIRES RESPONSIBLE FOR POWER DELIVERY WERE OBSERVED TO HAVE RESISTANCES WITHIN THE ACCEPTABLE RANGE. THE OUTER LAYERS OF THE MODULAR CABLE WERE STRIPPED, AND THE UNDERLYING WIRES WERE IN UNREMARKABLE CONDITION. PROVIDED INFORMATION INDICATED THAT THE PUMP-SIDE IN LINE CONNECTOR WAS CLEANED, WHICH RESOLVED THE ALARMS. THE ROOT CAUSE FOR THE REPORTED EVENT WAS NOT ABLE TO BE CONCLUSIVELY DETERMINED VIA THIS INVESTIGATION; HOWEVER, THE OBSERVED FLUID INGRESS ON THE IN-LINE CONNECTOR COULD HAVE CONTRIBUTED BY INTERFERING WITH THE ELECTRICAL CONNECTION. THE DEVICE HISTORY RECORDS WERE REVIEWED REVEALED NO DEVIATIONS WITH MANUFACTURING AND 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 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK (REV. D) SECTION 6 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 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.

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    TECH SERVICES CLEANED THE PUMP SIDE IN-LINE CONNECTOR AND THERE WERE NO DRIVELINE POWER FAULTS FOLLOWING THE CLEANING. IT WAS ALSO REPORTED BY THE SITE THAT THE PROXIMAL MODULAR CABLE WAS CORRODED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A NEW DRIVELINE POWER FAULT ALARM. LOG FILES WERE SUBMITTED FOR REVIEW AND CONFIRMED DRIVELINE POWER B FAULTS ON (B)(6) 2024. THE DRIVELINE DATA DRIFTED ENOUGH TO TRIGGER THE ALARM BUT THEN RETURNED TO NORMAL. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2024, AND THEIR MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED. THE PERIODIC LOG FILE FROM THE ORIGINAL CONTROLLER CONFIRMED THE DRIVELINE POWER FAULTS. LOG FILES WERE SENT POST-EXCHANGE, AND PER TECHNICAL SERVICES, THE DRIVELINE POWER FAULT DID NOT RETURN. IT WAS ADDITIONALLY COMMUNICATED ON (B)(6) 2024 THAT THE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT ON (B)(6) 2024, AND LOG FILE REVIEW WAS REQUESTED. THE LOG FILES CONFIRMED DRIVELINE POWER B FAULTS ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263408 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8830398 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male