BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21449090 · Received February 24, 2025

    Report

    Report Number
    1220648-2025-26291
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    January 25, 2025
    Report Date
    April 23, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF AUTOMATED IMPELLA CONTROLLER (AIC) - CONTROLLER FAILURE (RED ALARM) HAS BEEN COMPLETED. THE CONSOLE LOGS SHOWED THE QNX PROCESS IO-GRAPHICS CRASHED WHICH CAUSED THE AIC SOFTWARE TO REBOOT. THE CONSOLE REBOOTED IN RESPONSE FOLLOWED BY AN UNEXPECTED SHUTDOWN ALARM CONFIRMING WHAT WAS REPORTED CLINICALLY. THERAPY WAS RESUMED BEFORE THE PUMP WAS UNPLUGGED AND THE CONSOLE WAS SHUTDOWN. DEVICE ANALYSIS: THE FAILURE MODE WAS NOT REPRODUCED DURING INVESTIGATION ON ENGINEERING LAB BENCH. THE IO-GRAPHICS WAS FORCE SHUTDOWN USING A TELNET COMMAND AND THE CONSOLE RESPONDED THE SAME AS IN THE FIELD. ROOT CAUSE: THE CAUSE OF THE AIC ISSUE WAS THE 3RD PARTY HARDWARE/SOFTWARE THAT RUNS IO-GRAPHICS. E4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26291 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION.

    Additional Manufacturer Narrative · 0

    THE AUTOMATED IMPELLA CONTROLLER WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. THIS IS ONE OF TWO MANUFACTURING DEVICE REPORTS ASSOCIATED WITH THIS EVENT. REFER TO THE FOLLOWING MEDICAL DEVICE REPORT FOR AUTOMATED IMPELLA CONTROLLER (B)(6) WITH DATE OF EVENT 25-JAN-2025 AND PATIENT IDENTIFIER ENDING IN 6593 (THIS REPORT) MEDICAL DEVICE REPORT FOR IMPELLA 5.5 (B)(6) WITH DATE OF EVENT (B)(6) 2025 AND PATIENT IDENTIFIER ENDING IN (B)(6).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A/AN (UNKNOWN AGE) PATIENT WITH POST-CARDIOTOMY CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT (MCS). PRIOR TO IMPELLA MCS IT WAS NOTED THE PATIENT WAS ON VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO), INOTROPES/VASOPRESSORS AND RESPIRATORY (BILEVEL POSITIVE AIRWAY PRESSURE [BIPAP] OR CONTINUOUS POSITIVE AIRWAY PRESSURE [CPAP]) SUPPORT. APPROXIMATELY THREE DAYS AFTER START OF THE IMPELLA MCS A CALL FROM PERFUSIONIST WAS RECEIVED DUE TO AN OBSERVED SHORT BREAKDOWN FROM AUTOMATED IMPELLA CONTROLLER (AIC) WITH INDEPENDENT RESTART AND ALARM "CONSOLE FAILURE¿ AND NOTED ¿NOW PUMP WORKS WELL.¿ IT WAS RECOMMENDED THAT THE AIC BE TAKEN OUT OF SERVICE, WHICH APPEARS TO HAVE OCCURRED AFTER THE IMPLANT EXPERIENCE (EXACT DATE IS UNCLEAR, UNKNOWN). THERE WERE NO ADVERSE EFFECTS OR HARM TO THE PATIENT BECAUSE OF THE AIC CONSOLE FAILURE BASED ON THE REPORTED INFORMATION FROM THE REPORTER. THE PATIENT CONTINUED ON THE IMPELLA 5.5 MCS. THE PATIENT WOULD EXPIRE THREE DAYS LATER, HOWEVER, AS CARE WAS WITHDRAWN. ADDITIONAL INFORMATION WAS SOUGHT REGARDING DETAILS AROUND THE PATIENT¿S DEMISE AND THE FOLLOWING, ALTHOUGH LIMITED, WAS NOTED: REGARDING THE AIC, AFTER ITS INDEPENDENT REBOOT, THE PUMP MOTOR RESUMED AT THE PREVIOUS FLOW LEVEL, AND IT WAS STATED THIS DID NOT HAVE ANYTHING TO DO WITH THE PATIENT¿S DEMISE. IT WAS NOTED THAT THERAPY WAS STOPPED (CARE WAS WITHDRAWN) BECAUSE OF ¿OTHER DISEASE/COMORBIDITIES, WHICH WERE NOT HEART RELATED,¿ AND ¿THERE WAS NO WAY FOR A GOOD OUTCOME.¿ THESE OTHER ISSUES WERE NOTED AS MULTI-ORGAN FAILURE, MASSIVE CEREBRAL HEMORRHAGE AND INTESTINAL ISCHEMIA. IT IS UNKNOWN, HOWEVER, EXACTLY WHEN THESE ADVERSE EVENTS OCCURRED. CARE WAS WITHDRAWN FOR ADVERSE EXPERIENCES NOT CAUSED BY THE AIC AND GIVEN THE INFORMATION, AT LEAST ONE OF THE ADVERSE EVENTS IS LISTED AS A POTENTIAL OUTCOME WITH USE OF THE IMPELLA PUMP (CEREBRAL VASCULAR ACCIDENT CVA/CEREBRAL HEMORRHAGE). WITH NO ALTERNATIVE CAUSE FOR THE CVA EVENT IDENTIFIED AS THE LIKELY CAUSE, THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA 5.5 AS AN ASSOCIATED FACTOR IN THE PATIENT¿S DEMISE. MEDICAL SAFETY REVIEW OF THE EVENT NOTED FOR THE AIC, THERE WAS HEMODYNAMIC SUPPORT MAINTAINED AND REGARDING THE IMPELLA 5.5 DEVICE, HOWEVER, THERE IS NOT ENOUGH DATA TO ASSESS THE CVA IF IMPELLA PUMP RELATED; IT CANNOT BE EXCLUDED FROM THE OUTCOME (DEMISE) BASED ON THE LIMITED, INCOMPLETE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413125 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1221065 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male