BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 18827598 · Received March 4, 2024

    Report

    Report Number
    2916596-2024-01147
    Event Type
    Death
    Date Received
    March 4, 2024
    Date of Event
    February 8, 2024
    Report Date
    June 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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

    CORRECTED DATA: D1 BRAND NAME CORRECTED DATA: D4 CATALOG NUMBER CORRECTED DATA: D4 UDI MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, LOW FLOW ALARMS WERE CONFIRMED THROUGH REVIEW OF THE SUBMITTED LOG FILES. A SPECIFIC CAUSE FOR THE REPORTED ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A REVIEW OF THE SUBMITTED LOG FILES REVEALED CONTINUOUS LOW FLOW ALARMS, WHERE FLOW WAS CAPTURED AS LOW AS 0 LITERS PER MINUTE (LPM). NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED. IT WAS REPORTED THAT HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), WAS NOT EXPLANTED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICLE ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 4, ¿SYSTEM MONITOR,¿ EXPLAINS THAT THE LOW FLOW HAZARD ALARM OCCURS WHEN PUMP FLOW IS LESS THAN 2.5 LITERS PER MINUTE (LPM). A 10-SECOND DELAY IS IMPOSED BETWEEN THE DETECTION OF THE LOW FLOW STATUS AND THE ACTIVATION OF THE ASSOCIATED AUDIO AND VISUAL INDICATORS ON THE SYSTEM CONTROLLER. CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 7, ¿ALARMS AND TROUBLESHOOTING,¿ EXPLAINS ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK ALSO OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. 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 PASSED AWAY.

    Description of Event or Problem · 0

    LOG FILES WERE SUBMITTED FOLLOWING THE PATIENT'S DEATH THAT CAPTURED LOW FLOW EVENTS ON 08FEB2024 AT 7:10. IT WAS UNKNOWN IF THE DEATH WAS DEVICE OR THERAPY RELATED, AND IT WAS UNKNOWN IF THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178227 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6674346 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death