BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 19216793 · Received April 30, 2024

    Report

    Report Number
    2916596-2024-02470
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    April 7, 2024
    Report Date
    September 11, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013235
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CATALOG AND UDI NUMBER CORRECTED. H6: MEDICAL DEVICE PROBLEM CODES CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE BACKUP BATTERY BECOMING DEPLETED WAS CONFIRMED VIA LOG FILE ANALYSIS; HOWEVER, THE REPORTED EVENT OF THE CONTROLLER NOT ALARMING WAS UNABLE TO BE CONFIRMED. THE EVENT LOG FILE WAS REVIEWED, AND THE EXACT TIME SPAN OF THE DATA WAS UNABLE TO BE CONCLUSIVELY DETERMINED DUE TO THE CONTROLLER CLOCK RESETTING TO THE DEFAULT TIMESTAMP (06APR2024 ¿ 07APR2024, 01JAN2000 ¿ 06JAN2000 PER TIMESTAMP). STARTING ON 07APR2024 AT 1:21:43, WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU), LOW POWER HAZARD AND POWER CABLE DISCONNECT ALARMS ACTIVATED DUE TO A LOSS OF ALTERNATING CURRENT (AC) POWER. THE ALARMS TRANSITIONED INTO NO EXTERNAL POWER ALARMS AT 1:21:47. THE BACKUP BATTERY SUPPLIED POWER TO THE SYSTEM DUE TO THE LOSS OF EXTERNAL POWER. THE PUMP STOPPED AT 3:09:09 DUE TO THE BACKUP BATTERY POWER BEING DEPLETED. THE CONTROLLER LOST TOTAL POWER AND SHUTDOWN. THE CONTROLLER CLOCK WAS RESET TO THE DEFAULT TIMESTAMP OF 01JAN2000 AT 0:00:00, ONCE THE SYSTEM WAS RECONNECTED TO AC POWER. THE PUMP BEGAN OPERATING AT THE INTENDED SPEED WITHIN 5 SECONDS. THE HEARTMATE 3 SYSTEM CONTROLLER (SERIAL NUMBER HSC-121924) WAS NOT RETURNED FOR ANALYSIS. INFORMATION PROVIDED BY THE ACCOUNT STATED THAT A POWER OUTAGE AFFECTED THE AREA CAUSING THE LOSS OF EXTERNAL POWER. IT WAS STATED THAT THE PATIENT WAS SLEEPING WITH THE CONTROLLER BETWEEN HIMSELF AND THE MATTRESS. THE PATIENT WAS SYMPATHETIC WITH CHEST PAIN WHILE THE PUMP WAS OFF. A ROOT CAUSE FOR THE BACKUP BATTERY BECOMING FULLY DEPLETED AND THE CONTROLLER NOT ALARMING WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿) INSTRUCTS USERS THAT BACKUP BATTERY POWER SHOULD ONLY BE USED WHEN IN A POWER LOSS EMERGENCY. INAPPROPRIATE USE OF THE BACKUP BATTERY¿S POWER MAY RESULT IN DIMINISHED RUN TIME DURING A POWER LOSS EMERGENCY. THE BATTERY CAN PROVIDE ENOUGH POWER TO RUN THE PUMP FOR AT LEAST 15 MINUTES. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿) INSTRUCTS USERS ON HOW TO PROPERLY PERFORM A SYSTEM CONTROLLER SELF-TEST. USERS ARE ENCOURAGED TO PERFORM AT LEAST ONE SELF-TEST PER DAY TO ENSURE THE FUNCTION OF THE CONTROLLER¿S AUDIBLE AND VISUAL ALARMS. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿) INSTRUCTS USERS ON HOW TO REACT TO AND RESOLVE ALARMS THAT SOUND FROM THEIR SYSTEM CONTROLLER, INCLUDING ALARMS ASSOCIATED WITH NO EXTERNAL POWER (POWER OUTAGE) CONDITIONS. USERS ARE INSTRUCTED TO IMMEDIATELY SWITCH TO A WORKING POWER SOURCE. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION TITLED "EMERGENCY CONTACT LIST") CAUTIONS 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

    B1/H1: REPORT TYPE CORRECTED FROM MALFUNCTION TO SERIOUS INJURY. 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 THE PATIENT WAS IN CLINIC. THEY HAD AN ELECTRICAL FAILURE ON 07APR2024 AND STATED THEY NEVER HEARD THE SYSTEM CONTROLLER ALARMS THROUGH THE MOBILE POWER UNIT (MPU) WHEN THE PUMP WAS OFF. THEY WERE SLEEPING WITH THE SYSTEM CONTROLLER BETWEEN THEMSELVES AND THE MATTRESS. THE PATIENT WAS SYMPTOMATIC WITH CHEST PAIN WHILE THE PUMP WAS OFF BUT THIS IMMEDIATELY RESOLVED WHEN THE PUMP RESTARTED. PATIENT STATUS WAS NOT AFFECTED ONCE POWER WAS RESTORED. LOG FILES CAPTURED A LOSS OF POWER TO THE MPU AT 1:21 AM ON 07APR2024. THE SYSTEM WAS SUPPORTED BY THE EMERGENCY BACKUP BATTERY (EBB) UNTIL IT DEPLETED AND THE SYSTEM STOPPED AT 3:09 AM. THE MPU SEEMED TO WORK PROPERLY IN CLINIC, HOWEVER IT WAS EXCHANGED DUE TO THE PATIENT SAYING THERE WERE NO ALARMS WITH THE POWER OUTAGE THAT AFFECTED THEIR AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993105 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531US 8784851 00813024013235

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other