BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 19107359 · Received April 15, 2024

    Report

    Report Number
    1220648-2024-09866
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    April 9, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF PRIMING ISSUE HAS BEEN COMPLETED. THE LOGS CONFIRMED THE REPORTED COMPLAINT. THERE WERE MULTIPLE INSTANCES OF A PURGE SYSTEM FAILURE ALARM DUE TO A BLOCKED PISTON. 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. THE PURGE SYSTEM FAILURE WAS DUE TO BUILDUP OF GLUCOSE ON THE PURGE STEPPER MOTOR GASKET. D9 DATE DEVICE RETURNED TO MANUFACTURER ADDED THE FOLLOWING HAVE BEEN REPORTED INCORRECTLY OR MISSING FROM MANUFACTURER DEVICE REPORT 1220648-2024-09866. D2 COMMON DEVICE NAME, F6/F8-SHOULD HAVE BEEN LEFT BLANK, G1 REPORTING CONTACT FAX NUMBER MISSING.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 75-YEAR-OLD FEMALE OF UNKNOWN RACE AND ETHNICITY IN NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT DURING THE PRIMING PROCESS PRIOR TO PATIENT IMPLANT, THE NURSE COULD HEAR THE SOUND OF THE CASSETTE TRYING TO PRIME BUT THE AUTOMATED IMPELLA CONTROLLER (AIC) DISPLAYED A PURGE FLUID NOT DETECTED MESSAGE. THE SETUP WAS VERIFIED TO BE CORRECT. DESPITE TWO MORE ATTEMPTS, THE FAILURE PERSISTED. AS A RESULT, BOTH THE AIC AND PURGE CASSETTE WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769566 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1731799 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female