BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO AUTOMATION

    MDR report key: 8296682 · Received February 1, 2019

    Report

    Report Number
    3010825766-2019-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    December 19, 2018
    Report Date
    February 1, 2019
    Manufacturer
    INPECO SA
    Product Code
    JQP
    UDI-DI
    07640172342008
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION AND THE ANALYSIS OF THE AFFECTED COMPONENTS HAVE BEEN COMPLETED BY PRODUCT DISTRIBUTOR SERVICE PERSONNEL (FSE): THE COOLING UNIT AND THE XP4 COOLING POWER CONNECTOR WERE DAMAGED. AS IMMEDIATE ACTION, THE FSE REPLACED THE DAMAGED COMPONENTS (COOLING UNIT AND THE XP4 COOLING POWER CABLE). AFTER THE REPLACEMENT, THE EVENT HAS NOT OCCURRED ANYMORE AND THE SRM WORKED AS EXPECTED. THE PRODUCT DISTRIBUTOR CONFIRMED THAT NEITHER THE LABORATORY OPERATORS NOR THE SERVICE PERSONNEL CAME IN DIRECT CONTACT WITH THE AFFECTED COMPONENTS, AND THAT THERE WAS NO VISIBLE FIRE COMING FROM THE MODULE, ONLY SMOKE. THERE WAS NO INJURY ASSOCIATED TO THE EVENT AND THE PATIENT SAMPLE TUBES WERE NOT IMPACTED. THE ROOT CAUSE WAS NOT IDENTIFIED, AND IT HAS NOT BEEN POSSIBLE TO DETERMINE IF THE XP4 COOLING POWER CONNECTOR WAS THE ROOT CAUSE OR A REPERCUSSION. HOWEVER, THE ISSUE WAS A SINGLE EVENT WITH NO OTHER OCCURRENCE REPORTED FROM THE FIELD.THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NEITHER A FURTHER INVESTIGATION NOR A DESIGN CHANGE IS REQUIRED.

    Description of Event or Problem · 1

    THE PRODUCT DISTRIBUTOR HAS NOTIFIED INPECO THAT SMOKE AND STRONG SMELL WERE COMING FROM THE COOLING UNIT OF THE STORAGE AND RETRIEVAL MODULE (SRM). THE SRM STORES SAMPLE TUBES FROM THE AUTOMATION SYSTEM IN A TEMPERATURE CONTROLLED AND PROTECTED ENVIRONMENT. NEITHER THE LABORATORY STAFF NOR THE SERVICE PERSONNEL (FSE) WERE INJURED DUE TO THE EVENT. THERE WAS NO NEED FOR THE LABORATORY TO BE EVACUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90010 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM JQP INPECO SA AP2 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1