BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21057348 · Received January 2, 2025

    Report

    Report Number
    1220648-2025-25283
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 29, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE HAS NOT BEEN POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) BATTERY FAILURE RED ALARM AND YELLOW ALARM HAS BEEN COMPLETED. CONSOLE LOGS FROM THE REPORTED COMPLAINT DATE OF 2024.12.16 ARE CONSISTENT WITH THE COMPLAINT. THE AIC ISSUED MULTIPLE BATTERY FAILURE (TRANSPORT CONNECTION BLOWN/MISSING) [EVENT SET #360] AND CONTROLLER ERROR (LOSS OF COMM WITH KEYPAD OR BETWEEN THE KBD AND I2C FOR KBD HW REVISION 1) [EVENT SET #24] ALARMS ON THE COMPLAINT DATE. THE CONSOLE WAS RETURNED FOR EVALUATION. BOTH THE CONTROLLER ERROR AND THE BATTERY FAILURE WERE ABLE TO BE REPRODUCED. THE RESULTS OF RUNNING THE BATTTEST UTILITY ON TELNET REVEALED THAT THE CELL STACKS IN BOTH BATTERIES HAD VOLTAGES OF LESS THAN 2.5V WHICH RESULTED IN BATTERY LOCKOUT. A MISALIGNED COMMUNICATION RIBBON CABLE ON THE KBD WAS ALSO DISCOVERED AFTER INSPECTING THE INTERNAL COMPONENTS OF THE CONSOLE. THE REPORTED CONTROLLER ERROR WAS DETERMINED TO BE A LOSS OF COMMUNICATION ISSUE BETWEEN THE KBD AND 4-IN-1 DUE TO MISALIGNED COMMUNICATION RIBBON CABLE ON THE KBD. THE COMMUNICATION ERRORS RESOLVED AFTER RESEATING THE RIBBON CABLE. THE REPORTED BATTERY FAILURE ISSUE WAS DETERMINED TO BE CAUSED BY DEPLETED BATTERIES RESULTING IN BATTERY LOCKOUT. CONSOLE LOGS FROM THE REPORTED COMPLAINT DATE OF 2024.12.16 ARE CONSISTENT WITH THE COMPLAINT. THE AIC ISSUED MULTIPLE BATTERY FAILURE (TRANSPORT CONNECTION BLOWN/MISSING) [EVENT SET #360] AND CONTROLLER ERROR (LOSS OF COMM WITH KEYPAD OR BETWEEN THE KBD AND I2C FOR KBD HW REVISION 1) [EVENT SET #24] ALARMS ON THE COMPLAINT DATE. THE REPORTED CONTROLLER ERROR WAS DETERMINED TO BE A LOSS OF COMMUNICATION ISSUE BETWEEN THE KBD AND 4-IN-1 DUE TO MISALIGNED COMMUNICATION RIBBON CABLE ON THE KBD. THE COMMUNICATION ERRORS RESOLVED AFTER RESEATING THE RIBBON CABLE. THE REPORTED BATTERY FAILURE ISSUE WAS DETERMINED TO BE CAUSED BY DEPLETED BATTERIES RESULTING IN BATTERY LOCKOUT. ADDED D9 DEVICE RETURN DATE CORRECTIONS TO THE INITIAL MFR REPORT: H5 CORRECTED TO NO. H8 CORRECTED TO REUSE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD A CONTROLLER ERROR AND A BATTERY FAILURE ALARM. THE AIC WAS REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322967 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1701689 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown