BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 22027839 · Received May 15, 2025

    Report

    Report Number
    2916596-2025-03048
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 22, 2025
    Report Date
    October 21, 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
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A BACKUP BATTERY FAULT ALARM ON THE HEARTMATE 3 SYSTEM CONTROLLER (B)(6) WAS CONFIRMED. LOG FILES REVEALED ON (B)(6) 20225, 07:04:58, AN ATYPICAL INTERMITTENT BACKUP BATTERY FAULT ASSOCIATED WITH THE BACKUP BATTERY NOT PASSING THE LOAD TEST ACTIVATES. THE ALARM CLEARS BY 08:57:56. THE BACKUP BATTERY DID NOT PASS ITS LOAD TEST DUE TO THE LOADED VOLTAGE BEING UNDER THE ACCEPTABLE THRESHOLD AS COMPARED TO THE UNLOADED VOLTAGE. AT 10:51:53, A DRIVELINE DISCONNECT AND LVAD OFF ALARM ACTIVATES CONSISTENT WITH THE REPORTED CONTROLLER EXCHANGE. PUMP OPERATION WAS NOT AFFECTED. THE SYSTEM CONTROLLER WAS ALSO RETURNED FOR TESTING. THE CONTROLLER WAS THEN CONNECTED TO A MOCK LOOP, PATIENT CABLE, SYSTEM MONITOR, AND POWER MODULE. A SELF-TEST WAS PERFORMED, AND THE DISPLAY BUTTON WAS USED TO NAVIGATE THROUGH THE DIFFERENT DISPLAY SCREENS. OF NOTE AN INTERMITTENT BACKUP BATTERY FAULT ASSOCIATED WITH THE BACKUP BATTERY NOT PASSING THE LOAD TEST, ACTIVATED, CONFIRMING THE REPORTED EVENT. BOTH THE BLACK AND WHITE CABLES WERE DISCONNECTED, AND THE SYSTEM CONTROLLER ALARMED AND SWITCHED TO THE BACKUP BATTERY AS THE POWER SOURCE WITHOUT ISSUE. THE SYSTEM CONTROLLER WAS CONNECTED TO A MOCK CIRCULATORY LOOP FOR AN EXTENDED DURATION AND WAS ABLE TO OPERATE A PUMP WITHOUT ISSUE FOR EXTENDED OPERATION. THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS; HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED TO INVESTIGATE THE INCREASE IN REPORTED BACKUP BATTERY FAULTS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING AND QA SPECIFICATIONS. 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. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8, ENTITLED ¿EQUIPMENT STORAGE AND CARE¿, AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6, ENTITLED ¿CARING FOR EQUIPMENT¿, EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT, INCLUDING THE CONTROLLER AND THE POWER CABLES. 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. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN EMERGENCY BACKUP BATTERY (EBB) FAULT ON (B)(6) 2025. A NEW EBB WAS INSTALLED AND THE ALARM CLEARED ON (B)(6) 2025. AN EBB FAULT RETURNED ON (B)(6) 2025 AND CLEARED AFTER A FEW MINUTES. SINCE IT WAS THE SECOND FAULT, IT WAS DECIDED TO HAVE THE SYSTEM CONTROLLER REPLACED. THE MODULAR CABLE WAS ALSO REPLACED DUE TO DAMAGE ON THE EXTERNAL SLEEVE. LOG FILES WERE SENT FOR REVIEW AND THE EVENT LOG FILE RECORDED AN EBB FAULT EVENT ON (B)(6) 2025 AT 7:04:58. THIS EVENT APPEARED TO HAVE OCCURRED AFTER THE SYSTEM CONTROLLER ATTEMPTED A LOAD TEST. THE EBB FAULT RESOLVED WITH THE CONTROLLER EXCHANGE. THERE WAS NO IMPACT TO PUMP SUPPORT DUE TO THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011071 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US L00000437 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female