BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 22729964 · Received August 6, 2025

    Report

    Report Number
    1220648-2025-31072
    Event Type
    Death
    Date Received
    August 6, 2025
    Date of Event
    November 24, 2024
    Report Date
    October 2, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUE, PER FDA RECOMMENDATION. THE INVESTIGATION OF OPTICAL SIGNAL ISSUE HAS BEEN COMPLETED. NEITHER DATA LOGS NOR PRODUCT WERE AVAILABLE FOR INVESTIGATION. CLINICAL DETAILS DO NOT SUGGEST ANY POTENTIAL CAUSES FOR THE ALARM AND DO NOT MENTION ANY METHODS OF TROUBLESHOOTING THAT MAY HAVE RESOLVED THE ISSUE. DUE TO LIMITED INFORMATION, THE ROOT CAUSE OF THE OPTICAL SIGNAL ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTIONS THAT WERE MADE FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-31072. B1 ADVERSE EVENT UPDATED. B2 DEATH AND DEATH DATE UPDATED. B5 UPDATED TO INCLUDE DEATH DESCRIPTION. H6 UPDATED TO INCLUDE DEATH CODING.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE USE OF AN IMPELLA 5.5 PUMP FOR CIRCULATORY SUPPORT. DURING SUPPORT, THE PUMP TRIGGERED A PLACEMENT SIGNAL (PS) ALARM INDICATING THAT THE PLACEMENT SIGNAL WAS NOT RELIABLE. THE NURSE INSPECTED THE LINES AND CONFIRMED THERE WERE NO KINKS IN THE CABLE. ADDITIONALLY, THE PATIENT WAS NOT MOVING AT THE TIME THE ALARM OCCURRED. AN ECHOCARDIOGRAM WAS ORDERED TO VERIFY DEVICE POSITION, AND THE AUDIO FOR THE 'PS NOT RELIABLE' ALARM WAS DISABLED. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION CARE WAS EVENTUALLY WITHDRAWN, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528370 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025512870 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death