BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20595366 · Received November 3, 2024

    Report

    Report Number
    1220648-2024-21809
    Event Type
    Malfunction
    Date Received
    November 3, 2024
    Date of Event
    September 4, 2022
    Report Date
    November 3, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPELLA 5.5 SN: (B)(6) BEGAN ON CONSOLE (B)(6) ON (B)(6)2022. ALTHOUGH NOT TECHNICALLY PERSISTENT, SEVERAL PURGE ISSUES OCCURRED WITH THE CONSOLE ACROSS MULTIPLE PURGE CASSETTES OVER THE COURSE OF THE CASE DURATION ON (B)(6) FROM (B)(6) 2022 TO (B)(6) 2022. ON (B)(6) 2022 STAFF SWAPPED IMPELLA 5.5 SN: (B)(6) AND PURGE CASSETTE SN: (B)(6) TO (B)(6). PURGE ISSUES, AGAIN, ARE NOT PERSISTENT BUT DO OCCUR ON THE REPLACEMENT CONSOLE. DATA ANALYSIS: OCCURRING BEFORE THE REPORTED COMPLAINT DATE, ON (B)(6)2022, SEVERAL UNREPORTED PURGE RELATED ALARMS OCCURRED ACROSS MULTIPLE PURGE CASSETTES (SN'S (B)(6)): (B)(6)2022 19:52:59 IMCGUI: EVENT SET: #409 FROM 13 (0) - PURGE SYSTEM BLOCKED (B)(6)2022 19:53:59 IMCGUI: EVENT SET: #431 FROM 13 (0) - PURGE PRESSURE LOW (B)(6)2022 19:15:01 IMCGUI: EVENT SET: #408 FROM 13 (0) - PURGE PRESSURE HIGH (B)(6)2022 19:15:31 IMCGUI: EVENT SET: #409 FROM 13 (0) - PURGE SYSTEM BLOCKED (B)(6) 2022 19:17:28 IMCGUI: EVENT SET: #431 FROM 13 (0) - PURGE PRESSURE LOW (B)(6) 2022 16:24:11 IMCGUI: EVENT SET: #409 FROM 13 (0) - PURGE SYSTEM BLOCKED ON THE REPORTED COMPLAINT DATE OF (B)(6) 2022, STAFF BEGAN A PURGE BAG AND CASSETTE CHANGE WITH PURGE CASSETTE SN: (B)(6) WHEN THEY EXPERIENCED A CONTROLLER ERROR. 19:12:49 PURGEADMIN: PURGE SENSOR_DEFECT2 SET - PURGE: SENSOR DEFECTIVE (VOLTAGE OUT OF RANGE) 19:12:49 PURGEADMIN: PURGE_STOP - PURGE: STOP 19:12:49 IMCGUI: EVENT SET #418 FROM 13 (0) - CONTROLLER ERROR (PURGE PRESSURE SENSOR DEFECTIVE) THESE LOGS ERROR MESSAGES REPEATED SEVERAL TIMES THROUGH THE PURGE WIZARD, UNTIL THE PUMP WAS DISCONNECTED FROM (B)(6), AS THE CONTROLLER FAILURE WOULD NOT RESOLVE. RT LOGS WERE REVIEWED AT THE TIME OF THESE EVENTS OCCURRING. PURGE RELATED EVENTS OCCURRING FROM (B)(6) CAUSED FLUCTUATION IN PURGE PRESSURE HOWEVER NOT AN OVERALL LOSS OF PRESSURE. THE CONTROLLER FAILURE RELATED EVENTS CAUSED LARGE SPIKES IN PRESSURE, HOWEVER RESULTED IN AN OVERALL LOSS OF PURGE PRESSURE DURING THE PURGE CASSETTE AND BAG CHANGE. AFTER EXPERIENCING SEVERAL UNRESOLVABLE CONTROLLER FAILURES, STAFF SWAPPED THE PUMP AND LAST USED PURGE CASSETTE (SN (B)(6)) TO (B)(6). IMC LOGS FROM (B)(6) WERE REVIEWED. ALTHOUGH FOR SEVERAL DAYS THERE WERE NO ISSUES WITH PURGE RELATED FUNCTION, THE SAME ALARMS PREVIOUSLY SEEN ON (B)(6) WERE APPEARING ACROSS SEVERAL DIFFERENT CASSETTES AGAIN. DEVICE ANALYSIS: (B)(6) ARRIVED IN (B)(6). CONSOLE PURGE ASSEMBLY WAS INSPECTED, WITH SPECIAL ATTENTION TO THE PURGE PRESSURE SENSOR PCA AND RIBBON CABLE. NO OBSERVABLE ISSUES WERE FOUND. CONSOLE WAS TESTED RUNNING A PUMP AND PURGE SYSTEM BOTH INSIDE AND OUTSIDE OF THE BURN-IN ROOM. NO ISSUES OCCURRED IN EITHER TEST SCENARIO. DURING TESTING OUTSIDE OF THE BURN-IN ROOM, ON AN ENGINEERING LAB BENCH, A PURGE CASSETTE AND BAG CHANGE WAS ATTEMPTED. CONSOLE SUCCESSFULLY WENT THROUGH THE ASSOCIATED PURGE WIZARD WITH NO ISSUES. PURGE CMD BOLUS COMMAND WAS ALSO USED VIA TELNET, AND PURGE CASSETTE AND DISC WERE MANIPULATED IN AND OUT OF THEIR RESPECTIVE SPOTS PURPOSELY THROUGH THE WIZARD BUT NO ISSUES OCCURRED. CONTROLLER FAILURE COULD NOT BE REPRODUCED ON (B)(6). THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK / LOW CARDIAC OUTPUT SYNDROME WAS ON AN AUTOMATED IMPELLA CONTROLLER (AIC) FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT HAD A 5.5 SUPPORT ONGOING WHEN THE AIC FAILED AFTER A PC REPLACEMENT WAS DONE. THE TEAM FOLLOWED THE IFU AND UTILIZED A BACKUP AIC. NO HARM OR INJURY FROM THE AIC REPLACEMENT AND INTERRUPTION IN THE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631036 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1147986 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female