BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18985857 · Received March 27, 2024

    Report

    Report Number
    1220648-2024-08802
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 19, 2024
    Manufacturer
    ABIOMED, INC
    Product Code
    OZD
    UDI-DI
    00813502010985
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONSOLE (AIC) PURGE ISSUES. THE IMPELLA WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE PURGE ASSEMBLY REVEALED EXCESSIVE PURGE FLUID RESIDUE, INDICATING LEAKAGE OF PURGE FLUID DURING CLINICAL USE. PURGE FLUID RESIDUE WAS ALSO FOUND WITHIN THE PURGE MOTOR ASSEMBLY, PREVENTING THE PURGE MOTOR FROM SPINNING BOTH BY HAND AND VIA TELNET COMMANDS TO THE CONSOLE. LOGS WERE REVIEWED WHICH CONFIRMED THE REPORTED COMPLAINT. THERE WAS AN INSTANCE OF A PURGE SYSTEM FAILURE ALARM DUE TO A BLOCKED PISTON. THE ROOT CAUSE OF THE PURGE SYSTEM FAILURE WAS DUE TO BUILDUP OF GLUCOSE ON THE PURGE STEPPER MOTOR GASKET.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 64-YEAR-OLD MALE IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) PURGE SYSTEM FAILURE ALARM OCCURRED. IT WAS REPORTED THAT INSIDE THE PURGE DOOR WHERE THE CASSETTE FITS IN WHICH ROTATES FOR PURGE CASSETTE FUNCTION SEEMED TO BE LOCKED UP OR FROZEN ACCORDING TO CUSTOMER. THE AIC WAS EXCHANGED AND THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494343 AUTOMATED IMPELLA CONTROLLER AUTOMATED IMPELLA CONTROLLER (AIC) OZD ABIOMED, INC AUTOMATED IMPELLA CONTROLLER 1427009 00813502010985

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male