BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 22564769 · Received July 22, 2025

    Report

    Report Number
    1220648-2025-30574
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 5, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    PYX
    UDI-DI
    00813502011401
    PMA / PMN Number
    P170011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA ANALYSIS: ON 7/3, 5.5 PUMP (B)(6) WAS CONNECTED TO (B)(6). THE CONSOLE PERFORMS AS EXPECTED WITH USER KEYPRESSES LOGGED IN THE IMCLOGS THROUGH 7/5. STARTING AT 10:43, ACCOMPANYING KEYPRESSES WERE IMC-KBR ERRORS WHICH INDICATE THAT THE KEYBOARD SENSES AN OUT OF BOUNDS PRESS. THIS HAPPENS A TWO MORE TIMES BEFORE THE PUMP IS DISCONNECTED FROM THE CONSOLE WITH THE LAST SET OF KBD ERRORS NOT HAVING CORRESPONDING LOGGED KEYPRESS. DEVICE ANALYSIS: CONSOLE WAS RUN OVER MANY DAYS AND ROUTINELY TESTED FOR KEYBOARD FUNCTIONALITY WHICH NEVER FALTERED. THE CONSOLE PERFORMED AS EXPECTED THROUGHOUT TESTING. ROOT CAUSE: THE CAUSE OF THE KEYBOARD INTERFACE ISSUES COULD NOT BE DETERMINED BECAUSE THE FAILURE MODE DID NOT REPRODUCE DURING TESTING.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. SECTION A WAS LEFT BLANK. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE BUTTONS ON AN AUTOMATED IMPELLA CONTROLLER (AIC) BECAME UNRESPONSIVE AND THE USER WAS UNABLE TO CHANGE SCREENS OR MANAGE IMPELLA FLOWS. THE AIC WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817817 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP PYX ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1683279 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IMPELLA RP FLEX SN (B)(6)