BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24290419 · Received February 9, 2026

    Report

    Report Number
    1220648-2026-02539
    Event Type
    Death
    Date Received
    February 9, 2026
    Date of Event
    January 21, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: PPAE (ANEMIA): THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 2013882. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    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.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY IN A 58-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), FROM AN OUT-OF-HOSPITAL CARDIAC ARREST WITH CARDIOPULMONARY RESUSCITATION (CPR), IN SCAI STAGE D SHOCK, PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT DURING A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI). WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENTS HEMOGLOBIN/HEMATOCRIT (H&H) DROPPED, WHICH REQUIRED THE PATIENT TO RECEIVE 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS). THE POST-PROCEDURE OUTCOME WAS AN ESCALATION OF THERAPY TO AN IMPELLA 5.5. HOWEVER, THE SAME DAY THAT THE IMPELLA 5.5 WAS INSERTED, THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA 5.5 FUNCTIONED AT P-8 AT 3.4L/MIN. THE DEVICE IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE PATIENT'S CLINICAL CONDITION OF A CRITICALLY ILL PATIENT WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK AS THEY PRESENTED IN STAGE D SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354355 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026793894 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death