BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18711494 · Received February 15, 2024

    Report

    Report Number
    1220648-2024-06821
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    February 3, 2024
    Report Date
    February 15, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    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

    THE INVESTIGATION INTO THE SELF-CHECK ERROR ON THE AUTOMATED IMPELLA CONTROLLER (AIC) HAS BEEN COMPLETED. DATA ANALYSIS: IMC LOGS CONFIRM THAT THERE WAS LOSS OF COMMUNICATION BETWEEN THE PBM AND EPC AS EVIDENCED BY THE POWERMOD_1 COMMUNICATION FAILURE ERROR. I.E [(B)(6) 2024 13:58:00 SAU_SER10 RECEIVED DUPLICATE COMMAND SEQ: 43540. SEND ACK EOK !]. IT WAS ALSO CONFIRMED FROM THE LOGS THE SYSTEM SELF CHECK FAILURE OCCURRED AFTER THE MULTIPLE POWERMOD_1 COMMUNICATION ERRORS. I.E [(B)(6) 2024 13:58:00 SAU_SER10 RECEIVED DUPLICATE COMMAND SEQ: 43540. SEND ACK EOK !]. DEVICE ANALYSIS: THE FAILURE MODE WAS REPRODUCEABLE UPON BOOTUP IN THE LAB DURING INVESTIGATION. VISUAL INSPECTION OF THE PBM REVELED CORROSION OF THE COPPER VIA IN THE VICINITY OF THE SUPER CAPACITORS C69 AND C70. CONCLUSION: THE ROOT CAUSE OF THE SYSTEM SELF CHECK FAILURE WAS CONTAMINATION OF THE PBM BOARD FROM ELECTROLYTE LEAKAGE OF SUPER CAPACITORS. ELECTROLYTE LEAKAGE CORRODED TRACES OF THE PBM LEADING TO LOSS OF COMMUNICATION BETWEEN THE EPC AND THE PBM.

    Description of Event or Problem · 0

    THE COMPLAINANT IN JAPAN REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD A SYSTEM SELF CHECK ERROR ALARM. THE AIC WAS EXCHANGED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542223 AUTOMATED IMPELLA CONTROLLER AUTOMATED IMPELLA CONTROLLER (AIC) OZD ABIOMED, INC. OPTICAL AIC W/IMPELLA CONNECT 1578302

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown