BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21143548 · Received January 13, 2025

    Report

    Report Number
    2916596-2025-00150
    Event Type
    Death
    Date Received
    January 13, 2025
    Date of Event
    December 23, 2024
    Report Date
    February 3, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 COMPLETED.

    Additional Manufacturer Narrative · 0

    B2 - OUTCOMES ATTRIBUTED TO ADVERSE: CORRECTED. B2 - DATE OF DEATH: CORRECTED. THIS EVENT WAS DETERMINED TO BE SUPPLEMENTAL INFORMATION, AND THE INVESTIGATION FINDINGS WILL BE SUBMITTED UNDER MFR# 2916596-2024-05243. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS ADMITTED. THE PATIENT HAD AN ERODED MODULAR CABLE AND UNFORTUNATELY DID NOT RETURN TO HAVE IT REPAIRED. THE PATIENT HAD BEEN HAVING INTERMITTENT LOW FLOW ALARMS. THE OPPOSITE PORTION OF THEIR MODULAR CABLE THAT WAS ERODED AND COULD NOT BE REPLACED; THE SIDE THAT WAS CONNECTED TO THEIR DRIVELINE, AND PUMP. THE PATIENT PLANNED TO BE INPATIENT AT LEAST ANOTHER WEEK OR TWO. CARDIOTHORACIC SURGERY AND INFECTIOUS DISEASE TEAMS WERE CONSULTED FOR A PLAN OF CARE FOR A POCKET IN THEIR ABDOMEN NEAR THE DRIVELINE. LOG FILES CAPTURED LOW FLOW EVENTS ON (B)(6) 2024. THERE WERE ALSO SEVERAL LOW FLOW FLAGS. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2025. ADDITIONAL LOG FILES CAPTURED LOW FLOW EVENTS BEGINNING AT 7:42 PM ON (B)(6) 2025. THESE CONTINUED UNTIL 8:55 PM WITH FLOWS FLUCTUATING BETWEEN 2.4-2.5 LITER PER MINUTE (LPM). FURTHER LOW FLOW ALARMS OCCURRED STARTING AT 10:51 PM AND CONTINUED UNTIL THE DRIVELINE WAS DISCONNECTED AT 12:20 AM. FLOW VALUES DURING THIS PERIOD PROGRESSIVELY DROPPED FROM A BASELINE OF 3.5-4 LPM DOWN TO 0 LPM.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT PATIENT ORIGINALLY PRESENTED A COMMUNICATION FAULT BACK IN (B)(6) OF 2024, WAS SCHEDULED FOR A DRIVELINE CLEANING, BUT LEFT AGAINST MEDICAL ADVICE BEFORE THE CLEANING COULD BE PERFORMED. DRIVELINE CLEANING WAS PERFORMED ON (B)(6) 2025 WITH A MODULAR CABLE EXCHANGE. THIS EVENT WAS DETERMINED TO BE SUPPLEMENTAL INFORMATION TO MANUFACTURER REPORT NUMBER 2916596-2024-05243.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012799 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10032805 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention| D