BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR A3600

    MDR report key: 10983931 · Received December 10, 2020

    Report

    Report Number
    3010825766-2020-00009
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 10, 2020
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172341001
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INVESTIGATION, THE IDENTIFIED ROOT CAUSE IS THAT THE WIRES OF THE TRIPHASIC CABLE ON THE MAIN BLINDO CONNECTOR WERE PLUGGED WITH AN INCORRECT SEQUENCE. THIS CAUSED THE DAMAGE OF THE POWER SUPPLIES OF THE MODULES MENTIONED ABOVE WITH THE PRODUCTION OF FLAMES AND SMOKE. THE POWER SUPPLIES USED IN THE AUTOMATION SYSTEM ARE CERTIFIED FOR THE ELECTRICAL SAFETY AND THE FLAME AUTO-EXTINGUISHED, AS EXPECTED. AS CONSEQUENCE OF THIS EVENT TO RESTORE THE AUTOMATION SYSTEM FUNCTIONALITY, THE WIRES OF THE TRIPHASIC CABLE ON THE MAIN BLINDO CONNECTOR HAVE BEEN CORRECTLY PLUGGED AND THE POWER SUPPLIES OF THE INVOLVED MODULES HAVE BEEN REPLACED. THE AUTOMATION SYSTEM IS WORKING ACCORDING TO SPECIFICATIONS. THE INVESTIGATION HAS NOT HIGHLIGHTED ANY DEFICIENCY RELATED TO ACCELERATOR A3600 DESIGN. THERE HAVE BEEN NO PREVIOUS SIMILAR OCCURRENCES REPORTED FROM THE FIELD. TO AVOID ANY RE-OCCURRENCE, INPECO WILL TEST THE ASSEMBLED GROUP (CIRCUIT BREAKER, TRIPHASIC CABLE AND THE MAIN BLINDO PLUG) BEFORE THE SHIPMENT TO CHECK THE CORRECT TRIPHASIC WIRING SEQUENCE OF THE AUTOMATION SYSTEMS STILL IN MANUFACTURING. NO FURTHER ACTIONS ARE FORESEEN.

    Description of Event or Problem · 1

    THE EVENT OCCURRED DURING THE INSTALLATION OF THE AUTOMATION SYSTEM ACCELERATOR A3600 ACP.480. WHEN DISTRIBUTOR SERVICE PERSONNEL POWERED ON THE AUTOMATION SYSTEM FROM THE MAIN ELECTRICAL PANEL, THE POWER SUPPLIES OF SEVERAL MODULES OF THE AUTOMATION SYSTEM WERE DAMAGED. THE SERVICE PERSONNEL OBSERVED FLAMES FROM THE ELECTRICAL PANEL OF THE CENTRIFUGE MODULE #1 AND VISIBLE SMOKE FROM THE ELECTRICAL PANELS OF THE INPUT OUTPUT MODULE, STORAGE AND RETRIEVAL MODULE, CENTRIFUGE MODULE #2, AND (B)(4)INTERFACE MODULE. THE FIRE AUTO-EXTINGUISHED WITHOUT ANY INTERVENTION. NOBODY PRESENT IN THE LABORATORY WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453036 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM CEM INPECO SA ACP 07640172341001

    Patients

    Seq Age Sex Outcome Treatment
    1