BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 22005753 · Received May 12, 2025

    Report

    Report Number
    1220648-2025-28328
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 21, 2025
    Report Date
    June 12, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED. THE IMPELLA 5.5 ASSOCIATED WITH THIS AUTOMATED IMPELLA CONTROLLER WAS REPORTED IN MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-28326.

    Additional Manufacturer Narrative · 0

    DATA ANALYSIS: ON 3/27 5.5 PUMP 524733 WAS CONNECTED TO (B)(6) AND STARTED RUNNING AT 16:02. 77 MINUTES LATER, THERE IS THE LOG ENTRY "PMD OK STATEREC818 0 2000 257 0 0 0 0XA313 0XA313 CPLD 3" DIRECTLY PRECEDING SAU_MOTOR COMMUNICATION REINITIALIZING AND AN EVENT #115 PUMP STOP ((B)(6) 524733 25_03_27 PUMP STOP 1.PNG). THERE WAS ANOTHER PUMP STOP ON 3/31 WITH SIMILAR LOG ENTRIES BUT NO REINITIALIZATION OF SAU_MOTOR COMMUNICATION ((B)(6) 524733 25_03_31 PUMP STOP 2.PNG). THE PUMP WAS DISCONNECTED AND RECONNECTED ON 4/2 BY THE USER FOR NO DISCERNIBLE REASON IN THE LOGS. ON 4/6, THERE WAS ANOTHER PUMP STOP THAT OCCURRED TWICE IN QUICK SUCCESSION ((B)(6) 524733 25_04_06 PUMP STOP 3.PNG). THE PUMP WAS DISCONNECTED ON 4/7. ON 4/15, A NEW 5.5 PUMP, 581850, WAS CONNECTED TO (B)(6). ON 4/20 THERE IS ANOTHER PUMP STOP ((B)(6) 581850 25_04_20 PUMP STOP 4.PNG) THIS TIME WITH A NEW PUMP. THERE WERE TWO MORE BACK TO BACK PUMP STOPS ON 4/21 AT 8:57 AND THEN AGAIN AT 9:16 ((B)(6) 581850 25_04_21 PUMP STOP 5.PNG). THE PUMP WAS DISCONNECTED ON 4/22. IT WAS ALSO NOTICED FOR EVERY PUMP STOP, THAT AC POWER WAS DISCONNECTED. THE RT LOGS CONFIRM ALL OF THE PUMP STOPS BUT DO NOT EDIFY THE CAUSE. TIME STAMP PUMP AC POWER PMD STATEREC ALARMS PMD RESET AFTER SAU MOTOR ENTRIES SAU MOTOR RESET (B)(6) 2025 17:19:15, 524733. YES OK. 115. YES. YES. YES. (B)(6) 2025 17:19:43, 524733. YES OK. 115+18. NO. NO NO. (B)(6) 2025 13:09:06, 524733. YES OK. 115. YES. NO. NO. (B)(6) 2025 14:35:03, 524733. YES OK. 115. YES. NO. NO. (B)(6) 2025 14:35:06, 524733. YES OK. 115. NO. YES. NO. (B)(6) 2025 14:37:00, 524733. YES OK. 115. YES. YES. NO. (B)(6) 2025 08:38:50, 581850. YES OK. 115. YES. YES. NO. (B)(6) 2025 08:57:04, 581850. YES OK. 115. YES. YES. NO. (B)(6) 2025 09:15:58, 581850. YES OK. 115. YES. YES. YES. DEVICE ANALYSIS: THE CONSOLE WAS RUN OVERNIGHT TWICE WITH A PUMP ON P-8 (ALL PUMP STOPS WERE WITH THE PUMP ON P-8) BUT THE FAILURE MODE WAS NOT REPRODUCED. ADDITIONALLY A PUMP WAS RUN FOR MULTIPLE HOURS ON BATTERY POWER BUT STILL THE FAILURE MODE DID NOT REPRODUCE. ROOT CAUSE: THE CAUSE OF THE MULTIPLE PUMP STOPS ACROSS MULTIPLE PUMPS WAS NOT DETERMINED SINCE THE FAILURE MODE WAS NOT REPRODUCED. ROOT CAUSE: AS A PRECAUTION, PLEASE REPLACE THE IMPELLATRONIC BOARD (0042-1115) AND THE PBM (0042-1125), PLUS CONNECTORS 0042-2709 AND 0042-2711. THEN RUN A TEST PUMP ON BATTERY POWER FOR 30 MINUTES FOLLOWED BY SECTIONS 13-15 OF THE PM (0042-7309) AND FUNCTIONAL CHECK (0042-7316).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN IMPELLA 5.5 PUMP WAS IMPLANTED IN A PATIENT BEING ASSESSED FOR TRANSPLANT. THE PATIENT EXPERIENCED A STROKE. THE PATIENT SURVIVED AND LATER THE TEAM OBSERVED A PUMP STOP THAT WAS ABLE TO BE RESTARTED. THE PUMP REMAINS ON FOR SUPPORT. THE ASSOCIATED AUTOMATIC IMPELLA CONTROLLER (AIC) WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826078 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1883673 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male IMPELLA 5.5