BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21929999 · Received April 29, 2025

    Report

    Report Number
    1220648-2025-27957
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 9, 2025
    Report Date
    December 3, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012217
    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 WILL NOT BE RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED. DATA ANALYSIS: THE CONSOLE LOGS FROM THE REPORTED EVENT ON (B)(6) 2025, SHOWS FIRST PARTIAL RESTART OCCURRING AT (B)(6) 2025 13:32:44 WITH THE CONSOLE¿S SOFTWARE AUTOMATICALLY RESTARTING AFTER THE SHUTDOWN. THE REBOOT HAPPENED AFTER 5DAYS AND 11 HOURS OF PUMP OPERATION, FOLLOWING A PARTIAL RESET OF THE WATCHDOG (09/04/2025 13:32:31 WATCHDOG: PARTIAL RESET (B)(4)) AND A MISSED ACKNOWLEDGMENT BY PROCESS OSSI (09/04/25 13:32:31 PROCESS OSSIOPSENS NO HEARTBEAT (CHECK #2)!). FOLLOWING THE REBOOT, PUMP WAS RESUMED AND CASE CONTINUED FOR NEXT 3 HOUR TILL THE QNX PROCESS IO-GRAPHICS CRASHED WHICH CAUSED THE AIC SOFTWARE TO REBOOT (SYSTEMIDLE: PROCESS IO-GRAPHICS (B)(4) DIED ABNORMALLY). THIS 2ND REBOOT WAS ACCOMPANIED BY AN UNEXPECTED SHUTDOWN ALARM, AND THE PUMP FLOW DECREASED TO ZERO. ADDITIONALLY, THE IMPELLA DEFECTIVE ALARM (EVENT #3) WAS SEEN. FURTHER THE PUMP WAS UNPLUGGED AND THE CONSOLE SHUTDOWN. (B)(4). DEVICE ANALYSIS: CONSOLE (B)(6) WAS NOT RETURNED FOR INVESTIGATION DESPITE BEING REQUESTED. SEE 25-43182 - DEVICE RETURN INQUIRY.PDF NOTE: PLEASE REFER TO COMPLAINT (B)(4), WHICH ALSO INVOLVES (B)(6) WITH THE PUMP (SN: (B)(6)). BOTH CASES POINT TO THE SAME FAILURE MODE OF "AIC - SHUTDOWN OR RESTART ISSUE." HOWEVER, THE CONSOLE WAS ACCIDENTALLY CHECKED IN FOR COMPLAINT (B)(4) AND WAS NOT AVAILABLE FOR INVESTIGATION UNTIL IT WAS RETURNED AS PART OF COMPLAINT (B)(4). ROOT CAUSE: THE CAUSE OF THE UNEXPECTED RESTART (UNEXPECTED CONTROLLER ALARM) WAS NOT DETERMINED DUE TO THE INABILITY TO REPRODUCED. THE CAUSE OF THE PUMP STOP WAS NOT DETERMINED DUE TO THE INABILITY TO REPRODUCED. THE CAUSE OF THE PUMP NOT DETECTED (IMPELLA DEFECTIVE ALARM) WAS NOT DETERMINED DUE TO INABILITY TO REPRODUCE. D9: ADDED DEVICE RETURN DATE. H3: ADDED INFORMATION REGARDING THE INVESTIGATION STATUS. H6: ADDED CODES PER THE RESULTS OF THE INVESTIGATION. H10: ADDED THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AN CONSOLE (AIC) SUDDENLY WENT BLANK DURING IMPELLA SUPPORT. THE PERFUSIONIST PUSHED THE IMPELLA CABLE AND POWER CORD FIRMLY TOWARDS THE AIC HOUSING, BUT NOW A CONSOLE DEFECTIVE AND IMPELLA DEFECTIVE ALARM APPEARED. IMPELLA RESTART WAS INITIALLY NOT POSSIBLE. THE AIC WAS SWAPPED AND THE ISSUES RESOLVED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237967 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1786118 00813502012217

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male