BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 20418535 · Received October 10, 2024

    Report

    Report Number
    2916596-2024-06478
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 13, 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
    NJ, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10 - RELATED REPORT NUMBERS: CORRECTED MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF BACKUP BATTERY FAULT ALARMS WAS CONFIRMED. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: HSC-090108) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED (20240923_123715) FOR REVIEW THAT SHOWED EVENTS SPANNING APPROXIMATELY 7 DAYS (16SEP2024 ¿ 23SEP2024 PER TIMESTAMP). BACKUP BATTERY FAULT ALARMS DUE TO THE BACKUP BATTERY NOT PASSING THE LOAD TEST WERE ACTIVE ON 23SEP2024 FROM 10:15:38 ¿ 10:27:35. THE BACKUP BATTERY DID NOT PASS THE LOAD TEST DUE TO THE UNLOADED VOLTAGE BEING UNDER THE ALLOWED THRESHOLD. PUMP OPERATION WAS NOT AFFECTED BY THESE ALARMS. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. ADDITIONAL INFORMATION PROVIDED ON 13NOV2024 STATED THE EXCHANGED SYSTEM CONTROLLER WOULD NOT BE RETURNED FOR ANALYSIS. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTION INVESTIGATION WAS INITIATED TO INVESTIGATE BACKUP BATTERY FAULT ALARMS FURTHER. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER: HSC-090108) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. CUSTOMER ORDER WAS SHIPPED ON 21OCT2020. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) 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 (REV. C) SECTION 8 ENTITLED ¿CARING FOR THE EQUIPMENT¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 10 AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) (REV. C) SECTION F, BOTH ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CHANGED OUT THEIR PRIMARY SYSTEM CONTROLLER DUE TO A YELLOW ALARM DETERIORATING TO A RED ALARM. THE PATIENT DID NOT TAKE NOTE OF THE ALARM MESSAGE OR WHAT LIGHTS WERE ON THE SYSTEM CONTROLLER PRIOR TO THE EXCHANGE. PATIENT EXPERIENCED NO SYMPTOMS AND WAS IN THE EMERGENCY DEPARTMENT FOR EVALUATION. LOG FILES WERE SENT AND REVIEWED. THE EVENT LOG FROM (B)(6) CAPTURED LOW VOLTAGE HAZARD/NO EXTERNAL POWER EVENTS BACK ON (B)(6) 2024 AT 21:22 WHILE USING THE MOBILE POWER UNIT (MPU). IT APPEARED THAT THERE WAS A TOTAL LOSS OF POWER TO THE MPU, ENGAGING THE EMERGENCY BACKUP BATTERY (EBB) IN THE SYSTEM CONTROLLER UNTIL POWER WAS RESTORED TO THE MPU. THE EVENT LASTED AROUND 12 SECONDS. BACKUP BATTERY FAULTS WERE NOTED (B)(6) 2024 AT 10:15 DUE TO A FAILED EMERGENCY BACKUP BATTERY LOAD TEST. FOUR MINUTES LATER THE DRIVELINE WAS DISCONNECTED FROM THE SYSTEM CONTROLLER EXCHANGE REPORTED. THE EVENT LOG FROM THE CURRENT SYSTEM CONTROLLER (B)(6) CAPTURED SYSTEM CONTROLLER CLOCK CORRUPT EVENTS WHEN IT WAS CONNECTED. FROM THE LIMITED DATA AVAILABLE IT APPEARED THAT EVERYTHING WAS WORKING AS INTENDED. THERE WERE NO FURTHER EBB FAULTS. THE DATE AND TIME SYNCED (B)(6)2024 AT 12:18.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED THAT AFTER THE SYSTEM CONTROLLER EXCHANGE, LOG FILES DID NOT DEMONSTRATE ANY RED ALARMS, BUT THERE WAS AN EBB FAULT DUE TO A FAILED EBB LOAD TEST. THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THE EXCHANGE. THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD, AND IT DID NOT COME LOOSE AT THE WALL OUTLET OR FROM THE BACK OF THE UNIT. THERE WERE ENVIRONMENTAL CIRCUMSTANCES THAT AFFECTED AC POWER AT THE TIME OF THE EVENT. THE MPU WAS NOT EXCHANGED OR REMOVED FROM SERVICE AND THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816706 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7694137 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male