BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 19447263 · Received June 3, 2024

    Report

    Report Number
    1220648-2024-11936
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 28, 2024
    Report Date
    July 21, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1, A.4 AND A.5 ARE UNKNOWN. THE INVESTIGATION INTO THE AIC - PURGE DISC/FLAG ISSUES HAS BEEN COMPLETED. REVIEW OF THE LOGS CONFIRMED THE REPORTED ISSUE THAT A PURGE DISC COULD NOT BE DETECTED. ALTHOUGH IT WAS REPORTED TO HAVE OCCURRED ON ((B)(6) 2024), EVIDENCE IN THE IMC LOGS SUGGEST THAT IT OCCURRED ON ((B)(6) 2024) AND SEVERAL PAGES OF THE DATA SHEET CONTAINED MULTIPLE PURGE DISK NOT DETECTED ALARMS. THE PURGE DISC FLAG WAS RETURNED AND EVALUATED. IT WAS FOUND TO BE BROKEN (MISSING AT BLUE RETAINER). THE ROOT CAUSE OF THE ISSUE WAS A BROKEN PURGE DISC FLAG. A.3 REVISED AS SELECTION WAS INADVERTENTLY OMITTED FROM MANUFACTURER DEVICE REPORT 1220648-2024-11936. H.10 A.1, A.4 AND A.5 ARE UNKNOWN STATEMENT WAS INADVERTENTLY OMITTED FROM MANUFACTURER DEVICE REPORT 1220648-2024-11936. D.2 COMMON DEVICE NAME WAS REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT 1220648-2024-11936. D.4 LOT NUMBER WAS REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT 1220648-2024-11936. D.9 REVISED AS PREVIOUSLY ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT 1220648-2024-11936. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT 1220648-2024-11936 AND SHOULD NOT HAVE BEEN. G.1 REVISED REPORTING CONTACT FAX NUMBER IN ACCORDANCE WITH UPDATED PROCEDURES SINCE MANUFACTURER DEVICE REPORT 1220648-2024-11936 WAS SUBMITTED. G.2 REVISED SELECTIONS AS THEY WERE INADVERTENTLY OMITTED FROM MANUFACTURER DEVICE REPORT 1220648-2024-11936. H.3 IF THE DEVICE WAS NOT EVALUATED WAS ENTERED INCORRECTLY ON MANUFACTURER DEVICE REPORT 1220648-2024-11936 AND SHOULD OF REFLECT DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. H.6 ADDED CODE 4629 AS IT WAS INADVERTENTLY LEFT OFF MANUFACTURER DEVICE REPORT 1220648-2024-11936. H.6 CODES 4114 WAS REPORTED INCORRECTLY ON MANUFACTURER DEVICE REPORT 1220648-2024-11936. THE DEVICE WAS RETURNED ALREADY. H.10 ADDITIONAL MANUFACTURER NARRATIVE ON MANUFACTURER DEVICE REPORT 1220648-2024-11936 STATED THAT THE DEVICE WAS NOT RETURNED BUT THE DEVICE WAS ALREADY RETURNED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H.3 DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION ON ORIGINAL MANUFACTURER DEVICE REPORT 1220648-2024-11936 WAS SELECTED INCORRECTLY AND SHOULD OF REFLECTED THAT THE DEVICE WAS RETURNED. H.6 CODES 4121, 4112 AND 4110 WERE INADVERTENTLY LEFT OFF MANUFACTURER DEVICE REPORT 1220648-2024-11936 FOLLOW-UP NUMBER 1 AND WERE ADDED TO THIS REPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS UNABLE TO MOVE THROUGH ADDITIONAL PROMPTS TO FINISH THE PURGE CASSETTE CHANGE. THE PURGE CASSETTE/DISC WAS UNRECOGNIZABLE. THE AIC WAS REPLACED. NO PATIENT HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593958 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1687316 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown