BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 20130091 · Received September 3, 2024

    Report

    Report Number
    2916596-2024-05640
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    July 9, 2024
    Report Date
    January 23, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF FLUID INGRESS WAS CONFIRMED VIA EVALUATION. THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER 9173976) WAS RETURNED FOR ANALYSIS AND VISUAL INSPECTION REVEALED FLUID INGRESS ON INLINE CONNECTOR PINS. THE RETURNED MOD CABLE UNDERWENT FUNCTIONAL TESTING AND PASSED ALL TESTING PROCEDURES. THE MOD CABLE WAS CONNECTED TO THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(6)) AND SUCCESSFULLY OPERATED IN A MOCK CIRCULATORY LOOP FOR EXTENDED OPERATION WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. THE FLUID INGRESS DID NOT AFFECT MOD CABLE FUNCTIONALITY. INFORMATION PROVIDED BY THE ACCOUNT STATED THAT DRIVELINE FAULT ALARMS REACTIVATED, AFTER THE MODULAR CABLE WAS EXCHANGED. THE PUMP CABLE CONNECTION WAS PLANNED TO BE CLEANED AND HAS BEEN ADDRESSED VIA THE PUMP INVESTIGATION. THE ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 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 3 INSTRUCTIONS FOR USE (REV. C) SECTION 2 - ¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 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. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 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. 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

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE MODULAR CABLE CONNECTOR CLEANING WAS ATTEMPTED. THE DRIVELINE ON THE PUMP SIDE INLINE CONNECTOR WAS CLEANED. THERE WERE NO FURTHER ALARMS.

    Description of Event or Problem · 0

    VISUAL INSPECTION OF MODULAR CABLE CONNECTION NOTED FLUID INGRESS CAUSING OXIDATION WITHIN CONNECTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S SYSTEM CONTROLLER ALARMED FOR A DRIVELINE COMMUNICATION B FAULT ALARM ON 09JUL2024. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. ON (B)(6) 2024 THE PATIENT EXPERIENCED ANOTHER DRIVELINE COMMUNICATION B FAULT ALARM. THE LOG FILES ALSO SHOWED A DRIVELINE POWER FAULT ON 19JUL2024. X-RAYS WERE TAKEN OF THE DRIVELINE AND IT SHOWED A TIGHT LOOP IN THE PUMP END OF THE BEND RELIEF. THE PATIENT STATED THAT THE DRIVELINE WAS PULLED. THE PATIENT ARRIVED AT THE HOSPITAL ON (B)(6) 2024 FOR ASSESSMENT OF THE DRIVELINE BY AN ENGINEER. AFTER THE ASSESSMENT IT WAS DETERMINED THAT THE PUMP CABLE END WOULD BE CLEANED THE FOLLOWING MORNING ON 16AUG2024 DUE TO FLUID INGRESS OF THE MODULAR CABLE AND PUMP CABLE CONNECTION CAUSING OXIDATION. THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR STATED THAT THE PATIENT LEFT THE HOSPITAL UNDER TERMS OF RETURNING THE MORNING OF 16AUG2024 BUT NEVER DID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342317 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 9173976 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female