BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 19656141 · Received July 2, 2024

    Report

    Report Number
    2916596-2024-04189
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 20, 2024
    Report Date
    September 26, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    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

    SECTION D4: PRIMARY UDI CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A REVIEW OF THE SUBMITTED LOG FILES CONFIRMED THE REPORTED DRIVELINE COMMUNICATION FAULT ALARMS; HOWEVER, A SPECIFIC CAUSE FOR THE ALARMS CANNOT BE CONCLUSIVELY DETERMINED THROUGH THE EVALUATION OF THE RETURNED HEARTMATE 3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(6). A REVIEW OF THE SUBMITTED LOG FILES REVEALED A CONTINUOUS DRIVELINE COMMUNICATION FAULT ALARM. NO OTHER NOTABLE ALARMS WERE OBSERVED IN THE LOG FILES. THE ALARMS REMAINED ACTIVE UNTIL THE DRIVELINE WAS DISCONNECTED. THE DRIVELINE COMMUNICATION FAULT ALARMS DID NOT IMPACT THE CONTROLLER¿S ABILITY TO SUPPORT THE PUMP AND THERE WERE NO OTHER NOTABLE EVENTS CAPTURED ON THE REPORTED EVENT DATE IN THE LOG FILE. THE SYSTEM CONTROLLER UNDERWENT PRELIMINARY AND FUNCTIONAL TESTING AND WAS ABLE TO OPERATE A PUMP WITH NO ALARMS ACTIVE. THE REPORTED DRIVELINE COMMUNICATION FAULT ALARMS WERE UNABLE TO BE REPRODUCED DURING TESTING. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR HSC-091073 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE 3 PATIENT HANDBOOK SECTION 5, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, AND HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING DRIVELINE COMMUNICATION FAULT ALARMS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 2 - ¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK 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 SECTION 8 - ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 - ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE. HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE AND ENSURING THAT THE MODULAR IN-LINE CONNECTOR IS SECURE AND THE CONNECTOR LOCKING NUT IS IN THE LOCKED POSITION. HEARTMATE 3 PATIENT HANDBOOK CAUTIONS 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 PRESENTED WITH DRIVELINE COMMUNICATION FAULT ALARMS. THE CAUSE OF THE ALARMS WAS NOT IDENTIFIED. THE EVENT LOG FILES CAPTURED DRIVELINE COMMUNICATION FAULT ALARMS ON (B)(6) 2024 BETWEEN 7:30 PM AND 8:30 PM. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED WHICH RESOLVED THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760828 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7760389 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female