BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 25260192 · Received May 22, 2026

    Report

    Report Number
    2916596-2026-2916931
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 22, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED REPORT MFR# 2916596-2025-07148. 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'S SPOUSE CALLED ON (B)(6) 2026 WITH CONCERNS OF LOW FLOW ALARMS WHILE ON AC POWER AND THE PATIENT WAS QUITE DIZZY. THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2026 WITH STABLE BLOOD PRESSURES (BP) OF 97/75 AND 95/71 WITH A HEART RATE OF 89. THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) FLOW WAS 2.9 WITH SPEEDS OF 9400, PULSATILITY INDEX (PI) 4.4 AND POWER OF 4.6 WHILE ON BATTERIES. WHEN THE PATIENT'S WHITE CABLE WAS CONNECTED TO THE POWER MODULE WITH A GROUNDED CABLE, LOW SPEED ALARMS WERE NOTED ON THE SYSTEM CONTROLLER. THE PATIENT WAS ASYMPTOMATIC. THE GROUNDED CABLE WAS THEN EXCHANGED TO AN UNGROUNDED CABLE AND WHEN CONNECTED TO THE POWER MODULE, NO ALARMS OCCURRED. IT WAS NOTED THAT THE PATIENT FELL AGAINST A BAR COUNTERTOP APPROXIMATELY TWO WEEKS PRIOR DUE TO SOME DIZZINESS. THE PATIENT WAS ALSO QUITE PALE IN THE OFFICE AND WAS RECENTLY DIAGNOSED WITH ANEMIA OF UNKNOWN SOURCE. A UNIT OF BLOOD WAS GIVEN TO THE PATIENT FOR THEIR ANEMIA.THE PATIENT UNDERWENT A COSMETIC WIRE SURGERY ON (B)(6) 2025 (2916596-2025-07148). THE PATIENT WAS PLACED ON A LOANER POWER MODULE (PM) WHILE THE NEW PM ARRIVED WITH AN UNGROUNDED CABLE. THE ISSUES ONLY HAPPENED WHEN ON THE MOBILE POWER UNIT (MPU) AND NOT ON BATTERIES. THE USE OF THE PM WITH THE UNGROUNDED CABLE RESOLVED THE LOW FLOW ALARMS. LOG FILES WERE SUBMITTED FOR REVIEW. THE LOG FILES CAPTURED PERIODS OF LOW FLOW EVENTS THROUGHOUT THE LOG THAT APPEARED TO BE PATIENT RELATED AND NOT VENTRICULAR ASSIST DEVICE (VAD) NOR THE DRIVELINE. THE LOG FILES NOTED A LOW-SPEED HAZARD EVENT ON 04MAY2026 AT 1021 WITH SPEEDS NOTED AT 2520 RPM WHILE ON THE PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109398 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) Ventricular (assist) bypass DSQ THORATEC CORPORATION 106015 6045080 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention