BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24658851 · Received March 22, 2026

    Report

    Report Number
    1220648-2026-05757
    Event Type
    Death
    Date Received
    March 22, 2026
    Date of Event
    November 29, 2025
    Report Date
    March 22, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL CODES WERE UPDATED IN H6 (HEALTH EFFECT-IMPACT CODE, HEALTH-EFFECT-CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE). 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

    A 67 YEAR OLD MALE PATIENT WITH CARDIOGENIC SHOCK, ON ECMO AS PRIMARY SUPPORT DEVICE, IMPLANTED WITH IMPELLA CP TO ASSIST WITH LV UNLOADING. BILATERAL PLEURAL EFFUSIONS NOTED POST-CPR, AS NOTED BY PHYSICIAN. MASSIVE TRANSFUSION PROTOCOL ADMINISTERED, ANTI-COAGULANTS STOPPED. DURING CARE, PUMP IN AORTA ALARM NOTED. PUMP REPOSITIONED UNDER IMAGING. PATIENT CONTINUED TO DECOMPENSATE, AND WITHOUT AVAILABLE ADVANCED CARE OPTIONS, FAMILY WITHDREW CARE AND PATIENT EXPIRED. IMPELLA TO BE CONSERVATIVELY CODED TO RETROPERITONEAL HEMORRHAGE, BLOOD TRANSFUSION, AND DEATH, ALTHOUGH CPR AND ECMO THERAPY ARE LIKELY CONTRIBUTORS. ADDITIONAL INFORMATION: BILATERAL PLEURAL EFFUSIONS MD BELIEVES POSSIBLY FROM CHEST COMPRESSIONS POST CODE. CHEST TUBES PLACED - DRAINING RED BLOODY DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719318 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026769348 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| D