BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24067190 · Received January 14, 2026

    Report

    Report Number
    1220648-2026-00699
    Event Type
    Death
    Date Received
    January 14, 2026
    Date of Event
    January 4, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A6 IS UNKNOWN. 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. THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ADDITIONAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR 1220648-2026-00699 IS A DUPLICATE OF MFR 1220648-2026-01217. ALL INFORMATION FROM MFR 1220648-2026-00699 HAS BEEN CONSOLIDATED TO MFR 1220648-2026-01217. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED TO MFR 1220648-2026-01217.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED MULTIPLE SUCTION ALARMS AND DROPPING HEART RATE AND BLOOD PRESSURE. LEVOPHED AND ALBUMIN WERE GIVEN. THE PATIENT LOST PEDAL PULSES ON THE IMPELLA SIDE AND HAD BLEEDING FROM THE FASCIOTOMY SITE. THE WOUND VAC WAS CLOTTED OFF AND REMOVED. AN ULTRASOUND SHOWED NO FLOW IN THE PATIENT'S LEG AND THE PATIENT WAS EXPERIENCING PAIN. THE PATIENT HAS BEEN THROWING UP WITH RETCHING MOVEMENTS. HEPARIN WAS WITHHELD AND ONE UNIT OF PACKED RED BLOOD CELLS WAS TRANSFUSED. COMFORT CARE WAS PROVIDED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132925 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026755214

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Death