BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    MDR report key: 18892938 · Received March 13, 2024

    Report

    Report Number
    2916596-2024-01229
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 21, 2024
    Report Date
    May 29, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A LONG CONTINUOUS SCREECHING SOUND COMING FROM THE SYSTEM CONTROLLER WAS NOT CONFIRMED. THE REPORTED EVENT OF POWER CABLE DISCONNECT ALARMS WAS CONFIRMED VIA THE SUBMITTED LOG FILE. A REVIEW OF THE SUBMITTED CONTROLLER EVENT LOG FILE (091157) SPANNED APPROXIMATELY 24 DAYS (B)(6) 2024 PER TIME STAMP). ON (B)(6) 2024 AT 16:26:34, AND (B)(6) 2024 AT 09:24:50, 11:12:04, AND 11:33:28 WHILE CONNECTED TO BATTERIES, THE POWER CABLE DISCONNECT ALARM ACTIVATED DUE TO AN INVALID RELATIVE STATE OF CHARGE (RSOC) FAULT ASSOCIATED WITH THE WHITE POWER CABLE BEING OUTSIDE THE EXPECTED VOLTAGE RANGE. THE LOW VOLTAGE ALARM WAS ALSO INTERMITTENTLY ACTIVE ON (B)(6) 2024 AT 19:42:36, AND (B)(6) 2024 AT 07:54:01 AND 07:59:36 DUE TO FLUCTUATING RSOC VOLTAGE ON THE WHITE POWER CABLE. THE ALARMS WERE NOT ASSOCIATED WITH A POWER SOURCE EXCHANGE AND CLEARED SHORTLY AFTER EACH TIME. THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2024 AT 12:15:02 FOR A CONTROLLER EXCHANGE. THERE WERE NO NOTABLE ALARMS ACTIVE IN THE LOG FILE. SYSTEM CONTROLLER, SERIAL (B)(6), WAS NOT RETURNED FOR ANALYSIS. THE PROVIDED INFORMATION STATED THAT THE ALARM ALWAYS RESOLVES ITSELF BEFORE THE PATIENT CAN SEE WHAT IS ON THE DISPLAY SCREEN, AND PRESSING ALARM SILENCE AND DISPLAY BUTTON SHOWS NO ALARMS. THEY CONSEQUENTLY EXCHANGED THEIR CONTROLLER. A ROOT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. 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. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL ALARMS, INCLUDING POWER CABLE DISCONNECT AND LOW VOLTAGE ALARMS. HEARTMATE 3 INSTRUCTIONS FOR USE (REV. C) SECTION 8-¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK (REV. D) SECTION 6-¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY TAKE CARE AND MAINTAIN THE INTEGRITY OF THE SYSTEM CONTROLLER. THE DEVICE HISTORY RECORDS WERE REVIEWED WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT COMMUNICATED A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ALARM ON (B)(6) 2024 AT THE SAME TIME EACH MORNING FOR THE PAST 3 DAYS. THEY STATED THE SOUND WAS A LONG, CONTINUOUS SCREECH AND NOT A BEEP. IT ALWAYS RESOLVED ITSELF BEFORE THEY COULD SEE WHAT IT WAS ON THE DISPLAY AND PRESSING ALARM SILENCE AND DISPLAY BUTTON SHOWED NO ALARMS. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD CHANGED OUT THEIR SYSTEM CONTROLLER ON THEIR OWN ON (B)(6) 2024 DUE TO THE SAME ALARM OCCURRING, SO THEY WERE CURRENTLY ON THEIR BACKUP SYSTEM CONTROLLER. LOG FILES FROM THE BACKUP CONTROLLER CAPTURED SOME INTERMITTENT INDICATIONS OF A WEAK CONNECTION WHILE ON BATTERY POWER THAT APPEARED TO BE ONLY OCCURRING ON THE CONTROLLER¿S WHITE LEAD WHICH COULD BE CAUSED BY CONTROLLER POWER LEAD CABLE FATIGUE. ADDITIONAL LOG FILES WERE SENT FOR REVIEW ON THE PRIMARY CONTROLLER. THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY FROM PRIMARY CONTROLLER THAT WAS INITIALLY CHANGED OUT FOR THE ALARM ON (B)(6) 2024. THE LEFT VENTRICULAR ASSIST DEVICE COORDINATOR DISCUSSED TROUBLE SHOOTING WITH THE PATIENT PRIOR TO CHANGING OUT CONTROLLER IN THE FUTURE. THE PRIMARY SYSTEM CONTROLLER IS REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2024-01581.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026988 THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 7904183

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male