BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18312491 · Received December 12, 2023

    Report

    Report Number
    1220648-2023-05350
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 14, 2023
    Report Date
    February 10, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AIC WAS RECEIVED FROM THE CUSTOMER AND AN EVALUATION OF THE DEVICE IS ONGOING. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE AUTOMATED IMPELLA CONTROLLER (AIC) PURGE DISC/FLAG ISSUES HAS BEEN COMPLETED. THE CONSOLE LOGS CONFIRMED THAT THE PURGE DISC NOT DETECTED ALARM WAS ISSUED BUT QUICKLY RESOLVED ON THE FIRST INSERTION OF THE PUMP. THE CONSOLE WAS THEN ABLE TO PROCEED THROUGH PURGE PRIMING AS WELL AS OPTICAL BENCH CALIBRATION. THE PUMP WAS UNPLUGGED AND RE-PLUGGED INTO THE CONSOLE. THE CONSOLE WAS SHORTLY RESTARTED AFTER UNPLUGGING THE PUMP A SECOND TIME. IT WAS ON THE THIRD RESTART OF THE CONSOLE THAT MULTIPLE INSTANCES OF PURGE DISC NOT DETECTED ALARMS WERE ISSUED AS WELL AS OTHER PURGE ISSUES. REAL TIME LOGS CONFIRMED ANOMALOUS PURGE TICK BEHAVIOR WHEN MULTIPLE PURGE ISSUE ALARMS WERE ISSUED. INSPECTION OF THE CONSOLE REVEALED A CRACK IN THE PURGE RETAINER BUT IT IS NOT RELATED TO THE COMPLAINT. THE CONSOLE OPERATED TO SPECIFICATION WHEN A KNOW GOOD PUMP AND PURGE WERE RUN WITH IT. THE ROOT CAUSE FOR THE PURGE ISSUES IS MOST LIKELY DUE TO AN AIR GAP INTRODUCED INTO THE PURGE SYSTEM DURING CHANGE FROM ONE PURGE CASSETTE TO ANOTHER. THE FAILURE MODE COULD NOT BE REPRODUCED IN THE LAB. D.1 AND D.2 REVISED BRAND NAME AND COMMON DEVICE NAME SINCE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05350 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. D.4 REVISED MODEL NUMBER, CATALOG NUMBER, SERIAL NUMBER AND UNIQUE IDENTIFIER (UDI) # AS THEY WERE PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEIVCE REPORT NUMBER 1220648-2023-05350. E.1 REVISED US PHONE NUMBER AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEIVCE REPORT NUMBER 1220648-2023-05350. F.6 AND F.8 DATES WERE REPORTED ON MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05350 AND SHOULD NOT HAVE BEEN. G.1 REVISED REPORTING CONTACT EMAIL SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05350 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. REVISED REPORTING CONTACT FAX NUMBER AS IT WAS INADVERTENTLY OMITTED FROM THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-05350. H.4 REVISED DEVICE MANUFACTURE DATE AS IT WAS ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEIVCE REPORT NUMBER 1220648-2023-05350. H.6 CODES 4627 AND 2199 WERE REPORTED ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEIVCE REPORT NUMBER 1220648-2023-05350. A NEW CODE WAS ADDED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 73-YEAR-OLD MALE PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED THAT WHEN THE IMPELLA WAS INSERTED THROUGH THE SHEATH AND WAS IN THE ILIAC, THE PURGE PRESSURE LOW ALARM WAS TRIGGERED. THE PURGE NOT DETECTED ALARM AS WELL WAS TRIGGERED. THE STAFF NOTICED PURGE FLUID LEAKING FROM THE PURGE DISC WHEN THEY OPENED THE DOOR. THE MD THEN REMOVED THE IMPELLA FROM THE BODY. THE STAFF OPENED A NEW CASSETTE AND IT FAILED TO PRIME. A NEW CONSOLE WAS USED WITH THE SAME NEW CASSETTE AND THE IMPELLA PRIMED APPROPRIATELY. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304567 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1142509 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male