BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 20691039 · Received November 14, 2024

    Report

    Report Number
    2916596-2024-07285
    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
    00813024013235
    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 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) WAS RETURNED IN ASSOCIATION WITH DRIVELINE POWER FAULT ALARMS. THE SYSTEM CONTROLLER PASSED PRELIMINARY TESTING WITHOUT ISSUE OR ALARMS. A REVIEW OF THE SUBMITTED AND DOWNLOADED LOG FILES FROM THE REPORTED EVENT DATE OF (B)(6) 2024 SHOWED A DRIVELINE POWER FAULT ALARM ACTIVATING AT 00:40 DUE TO INTERMITTENT FLUCTUATIONS OF THE POWER A SIGNAL. 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. THE LOG FILES DID NOT SHOW ANY INDICATION OF AN ISSUE WITH THE SYSTEM CONTROLLER. THE ROOT CAUSE OF THE DRIVELINE POWER FAULT ALARMS WAS DETERMINED TO BE DUE TO DAMAGE TO THE MODULAR CABLE AND COULD NOT BE CORRELATED TO AN ISSUE WITH THE SYSTEM CONTROLLER. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND 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
    2223925 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7001563 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male