BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24605464 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05317
    Event Type
    Death
    Date Received
    March 16, 2026
    Date of Event
    November 25, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    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

    D4 REVISED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN D9. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, AND THE INVESTIGATION IS UNDERWAY. 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.

    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.

    Description of Event or Problem · 0

    61 YEAR OLD FEMALE CARDIOGENIC SHOCK PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) HAD AN IMPELLA CP INSERTED IN THE RIGHT FEMORAL ARTERY FOR LEFT VENTRICLE UNLOADING ECMO WAS PRIMARY SUPPORT DEVICE. A HEMATOMA FORMED NEAR ECMO SITE. AN IMPELLA RP FLEX WAS IMPLANTED FOR RIGHT VENTRICULAR SUPPORT DESPITE THE RISKS IDENTIFIED IN THE INSTRUCTIONS FOR USE. SUBSEQUENTLY THE PATIENT WAS DENIED TRANSFER TO ESCALATION FACILITY, AND THE FAMILY WITHDREW CARE. IMPELLA CP TO BE CONSERVATIVELY CODED TO HEMATOMA AND DEATH, ALTHOUGH THEY APPEAR RELATED TO ECMO SUPPORT AND THE PATIENTS CRITICAL SITUATION. RP FLEX TO BE CONSERVATIVELY CODED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348694 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026622911 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1