BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24206612 · Received January 28, 2026

    Report

    Report Number
    1220648-2026-01804
    Event Type
    Death
    Date Received
    January 28, 2026
    Date of Event
    November 25, 2024
    Report Date
    February 28, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: H6 CLINICAL CODES UPDATED TO INCLUDE E060104 AND E2321.

    Additional Manufacturer Narrative · 0

    ADDED: D10. CORRECTED: D1, D4 (SERIAL). ACCESS SITE ADVERSE EVENT/MAJOR BLEED: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. BRADYCARDIA/ HYPOTENSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    A 78-YEAR-OLD MALE WITH A HISTORY OF CARDIOMYOPATHY SUFFERED AN IN-HOSPITAL CARDIAC ARREST AND WAS CANNULATED FOR VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION AT BEDSIDE. AN IMPELLA CP WAS ADDED FOR VENTRICULAR UNLOADING. PROFUSE BLEEDING AT THE FEMORAL SHEATH SITE WAS NOTED. SYSTEMIC ANTICOAGULATION WAS HALTED DUE TO CONTINUED BLEEDING FROM CHEST TUBES. THE PATIENT EXPIRED AFTER TWO DAYS OF SUPPORT, MOST LIKELY ATTRIBUTED TO THE PATIENTS UNDERLYING CRITICAL CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19879 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 371 14F LT CMR SET 2025566801

    Patients

    Seq Age Sex Outcome Treatment
    1