BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24889082 · Received April 15, 2026

    Report

    Report Number
    2916596-2026-01966
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 18, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: PATIENT WEIGHT INFORMATION WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING LOW FLOW ALARMS, APPROXIMATELY 18 OVERNIGHT, WITH AN UNKNOWN ETIOLOGY. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PENDING AND THE PATIENT'S BLOOD PRESSURE WAS NOT ASSESSED DURING THE LOW FLOW ALARMS. THE ALARMS DID NOT PERSIST DURING THE DAY ON 27MAR2026. THE LOG FILES WERE SENT FOR REVIEW. THE EVENT LOG FILE CAPTURED LOW FLOW ALARM EVENTS ON 27MAR2026 AND 28MAR2026. THE ALARMS OCCURRED AT TIMES WHEN THE PULSATILITY INDEX (PI) WAS ELEVATED. IT WAS LATER REPORTED ON (B)(6) 2026 THAT THE PATIENT HAD A KNOWN OUTFLOW GRAFT OBSTRUCTION (OGO). THE PATIENT'S HEMATOCRIT LEVEL WAS SET FOR 20% AND ADDITIONAL LOG FILES WERE SENT FOR REVIEW. THE LOG FILES CAPTURED LOW FLOW ESTIMATES AND NONE WERE SUSTAINED LONG ENOUGH TO TRIGGER LOW FLOW HAZARD EVENTS WHEN THE CALCULATED PI WAS ELEVATED. BASED ON THE LOG FILES, THE MECHANICAL CIRCULATORY SYSTEM OPERATED AS INTENDED ELECTRONICALLY AND MECHANICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138798 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7321775 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female