BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21970353 · Received May 6, 2025

    Report

    Report Number
    1220648-2025-28133
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 15, 2025
    Report Date
    June 6, 2025
    Manufacturer
    ABIOMED, INC
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION, UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DATA ANALYSIS: CONSOLE LOGS FROM THE REPORTED DAY OF THE EVENT ARE CONSISTENT WITH THE COMPLAINT. ON THE COMPLAINT DATE IMMEDIATELY AFTER THE INITIAL CONSOLE BOOT-UP, THERE WAS A ¿CONTROLLER ERROR (DEFECTIVE OPTICAL SENSOR LAMP) - ALARM,¿ EVENT #1039. THIS INDICATES THAT THE REPORTED FAILURE OCCURRED. THE CONSOLE WAS THEN SHUT DOWN AND RESTARTED MULTIPLE TIMES, BUT EVENT #1039 HAPPENED EACH TIME. FURTHER INVESTIGATION INTO THE CONSOLE LOGS REVEALED A SIMILAR SITUATION WITH A PREVIOUSLY REPORTED CASE INVOLVING PUMP SN: (B)(6). THAT CASE DISPLAYED PSNR ALARM WITH MULTIPLE "ALGS SUSPENDED OPM SIGNAL INVALID" ERROR MESSAGES AS WELL AS THE CONTROLLER ERROR ALARM. ADDITIONALLY, THE LT LOG AND RT LOG SHOWED FLUCTUATING CONTRAST VALUES, WITH THE SIGNAL-TO-NOISE RATIO (SNR) DROPPING TO ZERO. SEE LT_LOG.PNG AND RT_LOG.PNG. DEVICE ANALYSIS: THIS CONSOLE WAS TESTED AFTER ARRIVING IN FS. UNABLE TO REPRODUCE THE REPORTED FAILURE BY POWER CYCLING THE CONSOLE. VOLTAGE FROM THE PBM AT CONNECTOR (J3) WAS 4.9V AND THE OPTICAL BENCH LAMP CONNECTOR (P4) WAS 4.8V. OBTAINED THE ANALOG OUTPUT FROM THE OPTICAL BENCH WITHOUT ANY NOISE OR DISTORTION WITH PUMP AND WITHOUT PUMP CONNECTED AS WELL AS 5S PARAMETER TESTING SHOWED THE LIGHT OUTPUT PASSING THE REQUIRED SPECIFICATION AND THE LAMP WAS VISIBLY OUTPUTTING LIGHT. SEE FRINGE_WOP.JPG, FRINGE_WP.JPG AND 5SPARAMETER.JPG. ROOT CAUSE: THE ROOT CAUSE FOR THE CONTROLLER ERROR (DEFECTIVE OPTICAL SENSOR LAMP) WAS MOST LIKELY DUE TO THE DEFECTIVE OPTICAL BENCH LAMP ASSEMBLY. CORRECTIVE ACTIONS: PIA-2024-0000252 WAS OPENED IN RESPONSE TO AN UPWARD COMPLAINT TREND IN AIC-CAUSED OPTICAL SIGNAL ISSUES. FAILURE OF THE OPTICAL BENCH¿S BULB WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE OPTICAL SIGNAL ISSUES. CAPA-014132 WAS OPENED TO IDENTIFY A POTENTIAL ENHANCEMENT OPPORTUNITY RELATED TO PROACTIVELY CHANGING THE TUNGSTEN BULB IN AIC'S OPTICAL BENCH. BEFORE RETURNING THE CONSOLE TO THE CUSTOMER, THE FOLLOWING ACTIONS ARE INSTRUCTED TO PERFORM: 1. REPLACE THE OPTICAL BENCH (0042-1012) DUE TO DEFECTIVE. 2. PERFORM SECTION 23 OF THE PREVENTATIVE MAINTENANCE PROCEDURE (0042-7309). 3. PERFORM A FULL FUNCTIONAL CHECK ON THE CONSOLE AND OPTICAL SYSTEM (0042-7316).

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE IMPELLA AIC HAD A CONTROLLER ERROR ON THE SCREEN. THE AIC WAS EXCHANGED. NO PATIENT WAS INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98441 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC AUTOMATED IMPELLA CONTROLLER 1356082 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown