BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24112206 · Received January 19, 2026

    Report

    Report Number
    1220648-2026-01096
    Event Type
    Death
    Date Received
    January 19, 2026
    Date of Event
    November 16, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PPAE (THROMBOCYTOPENIA, ANEMIA, MAJOR BLEED): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY (LOT): DEVICE LOT: 1961531. DEVICE HISTORY (BATCH): SUBCOMPONENT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN: (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    B5 UPDATED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT CONTINUES TO EXHIBIT THROMBOCYTOPENIA AND ANEMIA. THE SOURCE OF BLEEDING REMAINS UNCLEAR, WITH SEVERAL POTENTIAL CONTRIBUTING SITES, INCLUDING THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULATION SITES AND THE ONGOING CANGRELOR AND HEPARIN INFUSIONS. THE IMPELLA ACCESS SITE SHOWS NO EVIDENCE OF HEMATOMA OR ACTIVE BLEEDING. THE PATIENT SUBSEQUENTLY EXPIRED.

    Description of Event or Problem · 0

    THE COMPLAINANT PROVIDED ADDITIONAL INFORMATION UPON REQUEST: "1. THE INITIAL PUMP WAS SN (B)(6) (USED ELECTIVELY DURING THE HRPCI). THE PRODUCT IS NOT AVAILABLE FOR RETURN. TO BE CLEAR, THERE WAS NOTHING WRONG WITH THE PUMP ITSELF. THE MD MADE A DECISION TO REMOVE THE PUMP AS HE FELT THE PATIENT NO LONGER NEEDED IT. SHE THEN DECOMPENSATED AND HE USED AN ADDITIONAL PUMP (SN (B)(6)) TO SUPPORT THE PATIENT. 2. THE DEATH/ANEMIA/MAJOR BLEED WERE IN RELATION TO ECMO FOR WHICH SHE WAS SUBSEQUENTLY PLACED ON DURING HER HOSPITAL COURSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173353 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026731686 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death