BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 23832422 · Received December 17, 2025

    Report

    Report Number
    2916596-2025-08083
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 7, 2025
    Report Date
    January 26, 2026
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE REPORTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF BACKUP BATTERY FAULT ALARMS WAS CONFIRMED VIA ANALYSIS OF THE SUBMITTED LOG FILES; HOWEVER, THE ALARMS WERE NOT REPRODUCED DURING TESTING OF THE RETURNED SYSTEM CONTROLLER AND BACKUP BATTERY. SUBMITTED LOG FILES REVEALED A BACKUP BATTERY FAULT ALARM ON (B)(6) 2025 UNTIL THE SYSTEM CONTROLLER WAS EXCHANGED. THIS ALARM WAS DUE TO THE BACKUP BATTERY NOT PASSING THE LOAD TEST. THE ALARMS DID NOT AFFECT THE SYSTEM CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. PROVIDED INFORMATION REPORTED THAT THE PATIENT HAD EXCHANGED THEIR BACKUP BATTERY TWICE IN THE LAST 6 MONTHS. A SYSTEM CONTROLLER EXCHANGE WAS REPORTED TO BE DONE TO TROUBLESHOOT THE BACKUP BATTERY FAULT ALARM. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6) AND BACKUP BATTERY (SERIAL NUMBER: (B)(6) WERE FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED WITHOUT ANY ALARMS DURING ANALYSIS. THE SYSTEM CONTROLLER AND BACKUP BATTERY WERE ABLE TO COMPLETE A SELF-TEST AND SUPPORT A PUMP MOCK CIRCULATORY LOOP WITHOUT EXTERNAL POWER WITHOUT ANY ISSUES. DURING TESTING, MULTIPLE LOAD TESTS WERE PERFORMED AND THE BACKUP BATTERY PASSED EACH TIME WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. THE ROOT CAUSE FOR THE BACKUP BATTERY FAULT ALARM COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN INITIATED TO FURTHER INVESTIGATE BACKUP BATTERY FAULT ALARMS ON THE SYSTEM CONTROLLER. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) (REV. D) AND PATIENT HANDBOOK (REV. A) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING BACKUP BATTERY FAULT ALARMS. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOG FILES WERE SENT FOR ANALYSIS. PATIENT HAD EMERGENCY BACKUP BATTERY (EBB) FAULTS. THE PATIENT CHANGED THEIR EBB TWICE IN THE LAST 6 MONTHS (CS-221050; CS-221051). LOG FILES CONFIRMED INTERMITTENT EBB FAULT ALARMS ON (B)(6) 2025. THE EBB FAULT WAS DUE TO THE EBB FAILING THE LOAD TEST. THIS WAS ONLY AN ADVISORY ALARM AND THERE WAS NO PUMP INTERRUPTION DURING THIS EVENT. SINCE THE ALARMS WERE A RECURRING ISSUE, THERE WAS CONCERN THAT THERE WAS LIKELY A FRETTING CORROSION PRESENTS IN THE RIBBON CONNECTION FROM THE SYSTEM CONTROLLER. IT WAS RECOMMENDED TO REPLACE THE SYSTEM CONTROLLER IF IT WAS SAFE FOR THE PATIENT AND THEY COULD TOLERATE THE PUMP STOP ASSOCIATED WITH EXCHANGE. THE SYSTEM CONTROLLER EXCHANGE WAS SAID TO BE DONE. OTHERWISE, THERE WERE NO NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES. THE VENTRICULAR ASSIST DEVICE (VAD) WAS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041309 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US L00000300 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male