BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24408251 · Received February 20, 2026

    Report

    Report Number
    1220648-2026-03718
    Event Type
    Death
    Date Received
    February 20, 2026
    Date of Event
    December 16, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, AN INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. RELATED MEDICAL DEVICE REPORTS: THIS IS ONE OF THREE DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER(S) AS NOTED IN SECTION H10.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 BRAND NAME. CORRECTED D4 SERIAL NUMBER. CORRECTED D4 CATALOG NUMBER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED INFORMATION WAS PROVIDED IN D4. UPON REVIEW, THE PRIMARY UDI NUMBER HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE PATIENT WAS ON BIPELLA SUPPORT. THE 1ST IMPELLA CP HAD A POSITIONING / LOW FLOW ISSUE A COUPLE DAYS INTO SUPPORT, AND IT WAS REPLACED. BIPELLA SUPPORT CONTINUED. TWO DAYS LATER, THE PATIENT HAD PRESUMED HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) ATTRIBUTED TO THE RP FLEX. HOWEVER, BEFORE THE TEST RESULTS COULD CONFIRM, CARE WAS WITHDRAWN AND THE PATIENT THEN PASSED AWAY. THE DECISION TO WITHDRAW CARE WAS NOT ATTRIBUTED TO THE HIT. IN THIS CASE THE PATIENT'S UNDERLYING CONDITION CONTRIBUTED MOST TO THE DEMISE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467398 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026732579 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Life Threatening| D