BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 23542650 · Received November 13, 2025

    Report

    Report Number
    1220648-2025-48330
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 29, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502013276
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PRODUCT OR DATA LOGS WERE RETURNED FOR EVALUATION. HIGH PURGE PRESSURE: CLINICAL DETAILS NOTED THAT HIGH PURGE PRESSURE WAS NOTED ON FIRST DAY OF SUPPORT. PUMP WAS EXCHANGED THE FOLLOWING DAY. THE CAUSE OF THE HIGH PURGE PRESSURE COULD NOT BE DETERMINED AS NO PRODUCT OR LOGS WERE RETURNED FOR EVALUATION. DEVICE HISTORY LOT: DEVICE LOT: 1932200. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: PUMP SN (B)(6) PASSED ALL POST-STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT IN POST CARDIOTOMY CARDIOGENIC SHOCK¿AND WITH LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED ON THE FIRST DAY OF IMPELLA 5.5 SUPPORT THE PUMP EXPERIENCED HIGH PURGE PRESSURES WITH PRESSURES >1000 MMHG AND PURGE FLOWS < 1 ML/H. THE PHYSICIAN REQUESTED TISSUE PLASMINOGEN ACTIVATOR PROTOCOL. AS A RESULT OF THE UNRESOLVED HIGH PURGE PRESSURE, THE IMPELLA 5.5 WAS REPLACED WITH A NEW IMPELLA 5.5 PUMP THE FOLLOWING DAY. THE PUMP WAS SUCCESSFULLY EXCHANGED. AT THE TIME OF WRITING THIS REPORT, THE PATIENT CONTINUES TO BE SUPPORTED BY THE REPLACEMENT IMPELLA 5.5 WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141433 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026692687 00813502013276

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male