BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21910828 · Received April 25, 2025

    Report

    Report Number
    1220648-2025-27856
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 3, 2025
    Report Date
    June 2, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF AUTOMATED IMPELLA CONTROLLER (AIC) - CONTROLLER FAILURE (RED ALARM) HAS BEEN COMPLETED. THE CONSOLE LOGS SHOWED THE QNX PROCESS IO-GRAPHICS CRASHED WHICH CAUSED THE AIC SOFTWARE TO REBOOT (SYSTEMIDLE:PROCESS IO-GRAPHICS 339995 DIED ABNORMALLY). THIS REBOOT WAS ACCOMPANIED BY AN UNEXPECTED SHUTDOWN ALARM, AND THE PUMP FLOW DECREASED TO ZERO BEFORE IT WAS RESUMED AT THE PREVIOUS P-LEVEL PUMP FLOW. THERAPY CONTINUED BEFORE THE PUMP WAS UNPLUGGED, AND THE CONSOLE WAS THEN SAFELY POWERED DOWN. DEVICE ANALYSIS: THE FAILURE MODE WAS NOT REPRODUCED DURING INVESTIGATION ON ENGINEERING LAB BENCH. THE IO-GRAPHICS WAS FORCE SHUTDOWN USING A TELNET COMMAND AND THE CONSOLE RESPONDED THE SAME AS IN THE FIELD. ROOT CAUSE: THE CAUSE OF THE AIC ISSUE (UNEXPECTED SHUTDOWN ALARM) WAS THE 3RD PARTY HARDWARE/SOFTWARE THAT RUNS IO-GRAPHICS. NO ISSUES WERE IDENTIFIED WITHIN THE AIC CONSOLE RELATED TO THE REPORTED CONTROLLER FAILURE ALARM.

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AND ON DAY FOUR OF SUPPORT, THE AUTOMATED IMPELLA CONTROLLER (AIC) FAILURE RED ALARM OCCURRED AND REQUIRED REPLACEMENT OF THE AIC. REPORTEDLY THE PATIENT TOLERATED THE UNPLANNED AIC-TO-AIC EXCHANGE AND WAS IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826338 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1663431 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male