BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 13828320 · Received March 20, 2022

    Report

    Report Number
    2916596-2022-01737
    Event Type
    Malfunction
    Date Received
    March 20, 2022
    Date of Event
    March 5, 2022
    Report Date
    October 20, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q325-HF-4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BACKUP BATTERY FAULT WAS ABLE TO BE CONFIRMED VIA REVIEW OF THE LOG FILE. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: (B)(4)) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED FOR REVIEW (071649). A REVIEW OF THE SUBMITTED LOG FILES SHOWED 256 EVENTS SPANNING APPROXIMATELY 8 DAYS ((B)(6) 2022 PER TIMESTAMP). THE BACKUP BATTERY FAILED THE LOAD TEST DUE TO THE LOADED VOLTAGE BEING OVER THE ACCEPTABLE THRESHOLD AS COMPARE TO THE UNLOADED VOLTAGE. THE ALARMS DID NOT CLEAR IN THE LOG FILE; HOWEVER, IT WAS REPORTED THAT THE ALARMS CLEARED AFTER RESEATING THE BACKUP BATTERY. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. PUMP OPERATION WAS NOT AFFECTED. ADDITIONAL INFORMATION PROVIDED ON 15MAR2022 STATED THAT NO PRODUCT WILL BE RETURNING. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. HEARTMATE III INSTRUCTIONS FOR USE, REV. C, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK, REV. C, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING BACKUP BATTERY FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE III INSTRUCTIONS FOR USE, REV. C, ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK, REV. C, ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE INCLUDING HOW TO ENSURE THAT THE BACKUP BATTERY IS PROPERLY INSTALLED. 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. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE SYSTEM CONTROLLER (SERIAL NUMBER: (B(4)) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-01726. IT WAS REPORTED THAT THE PATIENT HAD A BACKUP BATTERY FAULT. THE CAREGIVER DID SOME TROUBLESHOOTING BY RE-SEATING THE BACKUP BATTERY IN THE CONTROLLER. A REVIEW OF THE LOG FILE REVEALED A SERIES OF BACKUP BATTERY FAULTS ON (B)(6) 2022. THE LOG FILE ALSO CAPTURED A SERIES OF NO EXTERNAL POWER EVENTS ON WHILE CONNECTED TO THE MOBILE POWER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7186 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531US 7726703 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female