BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24151381 · Received January 22, 2026

    Report

    Report Number
    1220648-2026-01317
    Event Type
    Death
    Date Received
    January 22, 2026
    Date of Event
    January 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. MECHANICAL INTERACTION WITH BLOOD/HEMOLYSIS: THE CAUSE WAS NOT ESTABLISHED DUE INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT OR DATA LOGS WERE RETURNED. DEVICE IN WRONG POSITION: THE CAUSE WAS NOT DETERMINED DUE TO LACK OF CLINICAL DETAILS AND NO PRODUCT RETURNED. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: A 39 YEAR OLD MALE PATIENT UNDERWENT SUPPORT WITH AN IMPELLA CP (PUMP 1: (B)(6); PC (B)(4); GU CASE (B)(6) FOR THE INDICATION OF ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE DEVICE WAS IMPLANTED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2026 AT 18:09. WHILE SUPPORTED WITH BOTH VA ECMO AND IMPELLA CP, THE CLINICAL TEAM OBSERVED PINK TO RED URINE IN THE FOLEY CATHETER AND LABORATORY EVIDENCE OF SEVERE HEMOLYSIS WITH LDH LEVELS GREATER THAN 10,000 U/L. SUSPECTED HEMOLYSIS PROMPTED IMPELLA REPOSITIONING AFTER IMAGING INDICATED THE DEVICE WAS MEASURING DEEP; THE PUMP WAS SUBSEQUENTLY OPERATING AT P 2. DESPITE ONGOING SUPPORT, THE PATIENT EXPIRED ON (B)(6) 2026 WHILE ON VA ECMO AND IMPELLA; NO CAUSE OF DEATH WAS PROVIDED. DEVICE RELATED FAILURE MODES UNDER CONSIDERATION INCLUDE HEMOLYSIS AND MALPOSITION; RETURN OF THE DEVICE IS NOT EXPECTED AT THIS TIME, AND PHYSICAL INSPECTION CANNOT BE PERFORMED. HEMOLYSIS IS CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA CP BUT IS UNLIKELY A CONTRIBUTING FACTOR AND IS MOST LIKELY ATTRIBUTED TO PATIENTS UNDERLYING CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297722 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026737687 813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention| D