BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 23331509 · Received October 18, 2025

    Report

    Report Number
    1220648-2025-31870
    Event Type
    Malfunction
    Date Received
    October 18, 2025
    Date of Event
    February 7, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010428
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OPTICAL SIGNAL ISSUES, PER FDA RECOMMENDATION. THE INVESTIGATION HAS BEEN COMPLETED. DATA ANALYSIS: THERE WERE NO SIGNS IN THE IMC OR LT/RT LOGS OF NO PURGE FLUID FLOWING AS DESCRIBED IN THE COMPLAINT. (B)(4) STARTED WITH PURGE CASSETTE 172319 AND CP PUMP 561659. THE CONSOLE SUCCESSFULLY PRIMES BUT THE USER DOES NOT COMPLETE STEP 7 STARTING THE CASE. THE CONSOLE IS POWER CYCLED, AND THE SAME PUMP AND CASSETTE SKIP CASE WIZARD SINCE THE PUMP IS ALREADY INITIALIZED BUT THE USER DOES NOT TURN ON THE PUMP. THE CONSOLE IS POWER CYCLED AGAIN AND NEW PURGE CASSETTE (161940) AND PUMP (545263) ARE INSERTED AND AGAIN THE CONSOLE PRIMES SUCCESSFULLY BUT THIS TIME THE USER COMPLETES THE PURGE WIZARD AND STARTS THE PUMP. THE RT LOG CONFIRMS THE CONSOLE SUCCESSFULLY PRIMED WITH PURGE FLOWING WITH THE FIRST PUMP. DEVICE ANALYSIS: THE COMPLAINT WAS NOT REPRODUCED DURING TESTING. PURGE AND PUMP WERE PRIMED SUCCESSFULLY AND FLUID WAS FLOWING AS EXPECTED. ROOT CAUSE: THERE WAS NO ISSUE FOUND WITH PURGE FLUID NOT FLOWING DURING THE CASE. THERE WAS NO ISSUE FOUND WITH THE OPTICAL SIGNAL DURING THE CASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUSPECT PRODUCT AND HISTORICAL COMPLAINT DATA WAS CONDUCTED. THIS REVIEW REVEALED THAT THE PRODUCT MET ALL MANUFACTURING RELEASE CRITERIA, AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED AT THE TIME THE PRODUCT WAS MANUFACTURED AND RELEASED TO THE CUSTOMER. ALL PERTINENT INFORMATION AVAILABLE TO ABIOMED HAS BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT UPON ATTEMPTING TO PRIME THE SETUP, NO PURGE FLUID WAS OBSERVED FLOWING OUT OF THE PUMP ASSEMBLY. IT WAS NOTED THAT THE PURGE LINE HAD BEEN SUCCESSFULLY PRIMED PRIOR TO THE PUMP BEING ATTACHED. THE PUMP WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM. AUTOMATED IMPELLA CONTROLLER REPLACEMENT WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369251 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1383536 00813502010428

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male IMPELLA CP