BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 23831293 · Received December 17, 2025

    Report

    Report Number
    1220648-2025-49118
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    September 13, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010961
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS BEEN RECEIVED BUT HAS NOT YET BEEN EVALUATED. WHEN THE DEVICE INVESTIGATION HAS BEEN COMPLETED OR ANY NEW INFORMATION HAS BEEN RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DATA ANALYSIS: CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW SEVERAL PURGE-RELATED ALARMS PURGE PRESSURE HIGH (#408) AND PURGE SYSTEM BLOCKED (#409) WHICH SEEM TO SELF-RESOLVE. LTLOG AND RTLOG DATA SHOWS VALUES OF PURGE PRESSURE INCREASING UP TO 1200MMHG OR DROP TO ZERO, WITH BOTH PURGE CASSETTES THAT WERE USED DURING THIS CASE. REPLACING THE PURGE CASSETTE DID NOT RESOLVE THE ISSUE, REDUCED ITS SEVERITY AND FREQUENCY OF ALARMS. DEVICE ANALYSIS: CONSOLE WAS TESTED AT FS AND ITS PURGE SYSTEM WAS FOUND TO BE OPERATING WITHIN SPECIFICATION - BOTH, THE PURGE MOTOR AND PURGE PRESSURE SENSOR WERE CONFIRMED TO BE WORKING AS EXPECTED. SEPARATE INVESTIGATION ((B)(4)) INTO PURGE CASSETTES 61648, 190694 AND PUMP 611116 DID NOT IDENTIFY ROOT CAUSE, AS ALL DEVICES WERE WORKING AS EXPECTED DURING TESTING. ROOT CAUSE: THE ROOT CAUSE OF PURGE PRESSURE FLUCTUATIONS COULD NOT BE DETERMINED BECAUSE IT COULD NOT BE REPRODUCED. DEVICE HISTORY LOT N/A. DEVICE HISTORY BATCH N/A. DEVICE HISTORY REVIEW: Q1) SERVICE HISTORY REVIEW - ARE THERE AN QNS ASSOCIATED WITH THE COMPLAINT DEVICE¿S MOST RECENT SERVICE REPORT? NO. Q2) SUBCOMPONENT LOT REVIEW - WERE THERE ANY OTHER PRODUCT MALFUNCTION COMPLAINTS IN THIS SUBCOMPONENT LOT RELATED TO THIS FAILURE MODE? N/A. Q3) COMPLAINT HISTORY REVIEW - HAVE THERE BEEN ANY OTHER COMPLAINTS AGAINST THIS CONSOLE? NO. THERE WERE NO ISSUES RELATED TO COMPLAINT DISCOVERED WHEN REVIEWING THE PRODUCT HISTORY OF CONSOLE (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PURGE SYSTEM WAS SUCCESSFULLY CHANGED AND THE PURGE PRESSURES WERE WITHIN THE NORMAL RANGE. THEY WANT TO BEGAN WEANING THE PUMP. THE DEFECTIVE PURGE SYSTEM CAN BE PICKED UP FROM THE CARDIOTECHNICS DEPARTMENT IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186562 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1322187 00813502010961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown