BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16861003 · Received May 3, 2023

    Report

    Report Number
    2916596-2023-02351
    Event Type
    Death
    Date Received
    May 3, 2023
    Date of Event
    April 8, 2023
    Report Date
    May 15, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED MFR # FOR THE CONTROLLER: 2916596-2023-02491. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT (B)(6) WILL NOT BE RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING AND QA (QUALITY ASSURANCE) SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IUF) IS CURRENTLY AVAILABLE. THE HEARTMATE 3 LVAS IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING DEATH. 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 WAS FOUND DEAD WITH ARMS CROSSED ON THEIR COUCH BY A NEIGHBOR LATE EVENING OF (B)(6) 2023 OR EARLY MORNING 0F (B)(6) 2023. ON (B)(6) 2023, THE PATIENT SPOKEN TO THEIR FAMILY AROUND 20-2030. THE EMERGENCY MEDICAL TECHNICIAN (EMT) REPORTED TO A FAMILY MEMBER THAT THE PATIENT WAS "UNHOOKED" WHEN THEY ARRIVED. WHEN THEY ATTEMPTED TO HOOK THE PATIENT UP, BOTH BATTERIES WERE NOTED TO BE DEAD. THE EMTS DID NOT REPORT IF THE CONTROLLER WAS ALARMING OR NOT UPON THEIR ARRIVAL. PER FAMILY, IT DID NOT APPEAR THAT THE PATIENT WAS TRYING TO CHANGE BATTERIES, SYSTEM CONTROLLER, OR THAT THE PATIENT MESSED WITH THEIR EQUIPMENT. THE PATIENT REPORTEDLY HAD NO ISSUES MANAGING THEIR VENTRICULAR ASSIST DEVICE (VAD) OR EQUIPMENT. IT WAS NOTED THAT THE PATIENT'S SPOUSE PASSED AWAY ON (B)(6) 2023 AND THE PATIENT TOOK THE DEATH VERY HARD. THE EVENT LOG CAPTURED ROUTINE EVENTS UNTIL (B)(6) 2023 AT 0146 WHERE THE LOG CAPTURED LOW VOLTAGE ADVISORY EVENTS ON BATTERY POWER. THE ADVISORY EVENTS TURNED INTO HAZARD EVENTS AT 0255 AND APPEARED THAT THE 14V BATTERY RAN OUT OF POWER AT 0307. THE EMERGENCY BACKUP BATTERY (EBB) ENGAGED AT THAT TIME AND POWERED THE PUMP AT 5100 ROTATIONS PER MINUTE (RPM) UNTIL IT TOO WAS DEPLETED AT 0510 AND THE VAD WAS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714185 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7316092 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death