BEUDAMED
    FDA Adverse Event Death Summary report: N

    APTIO AUTOMATION

    MDR report key: 8845999 · Received July 31, 2019

    Report

    Report Number
    3010825766-2019-00008
    Event Type
    Death
    Date Received
    July 31, 2019
    Date of Event
    July 23, 2019
    Report Date
    July 31, 2019
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172342008
    PMA / PMN Number
    K121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE TUBE OF THE PATIENT INVOLVED IN THE INCIDENT WAS SCHEDULED TO BE JUST CENTRIFUGED ON THE CENTRIFUGE CONNECTED TO THE AUTOMATION SYSTEM AND THEN UNLOADED FROM THE AUTOMATION SYSTEM IN ORDER TO BE MANUALLY PROCESSED THROUGH AN ANALYZER. THE LOG FILES ANALYSIS SHOWS THAT AT THE 2.49 AM THE TEST ORDER WAS SENT FROM LABORATORY INFORMATION SYSTEM TO THE AUTOMATION SYSTEM; THE SAMPLE TUBE WAS LOADED ON THE AUTOMATION SYSTEM AND AT THE 3.10 AM IT WAS DIVERTED TO THE CENTRIFUGE MODULE (CM). THEN, AT 3.27 AM THE ERROR 06B0 "SAFETY SHIELD OPEN" WAS GENERATED: THIS ERROR IS DISPLAYED ON THE AUTOMATION SYSTEM SOFTWARE USER INTERFACE WHEN THE CM SAFETY SHIELD IS OPENED BY THE USER WHILE THE CM IS OPERATIONAL. IN THIS SITUATION, THE CM STOPS WORKING AND NO ACTIONS IS PERFORMED ON THE TUBES ALREADY DIVERTED IN THE CM: THIS ERROR REQUIRES USER INTERVENTION TO BE SOLVED, AS PER THE STEP BY STEP RECOVERY DISPLAYED ON THE USER INTERFACE. THE USER STARTED THE ERROR RECOVERY AT 3.46 AM AND COMPLETED THE PROCEDURE AT 3.50 AM. AT 3.51 AM THE TUBE OF THE PATIENT INVOLVED IN THE INCIDENT WAS LOADED BACK ON THE AUTOMATION TRACK. AT 3.53 AM THE TUBE WAS UNLOADED INTO A RACK OF THE INPUT/OUTPUT MODULE IN ORDER TO BE MANUALLY MANAGED BY THE USER AND BE MANUALLY LOADED INTO THE REQUIRED ANALYZER. THE USER IS A TRAINED PERSON ON THE USE OF THE AUTOMATION SYSTEM, SO HE/SHE IS AWARE OF THE ERROR STATE OF THE CM THROUGH THE ERROR POSTED ON THE SOFTWARE USER INTERFACE. THE ROOT CAUSE OF THE ERROR 06B0 IS UNKNOWN. MOREOVER, THE INPECO AUTOMATION SYSTEM ALLOWS THE USER TO CLASSIFY THE TUBES AS ROUTINE OR PRIORITY TUBES (STAT) AND IN CASE OF A STAT TUBE THE MANAGEMENT OF PROCESS AND TESTING IS FASTER. ACTUALLY, THE AUTOMATION SYSTEM PROVIDES THE MEANS TO RESERVE PLACES IN EACH MODULE QUEUE TO STAT SAMPLES (EVEN THE ENTIRE QUEUE). IN THIS SPECIFIC CASE, ALTHOUGH THE TUBE WAS AN EMERGENCY TUBE, IT WAS NOT CLASSIFIED AS STAT. THE INPECO AUTOMATION SYSTEM BEHAVED AS EXPECTED. THE INSTRUCTIONS FOR THE ERROR RECOVERY ARE CONSIDERED ADEQUATE, SO NO DESIGN CHANGE IS FORESEEN: NO FIELD SAFETY CORRECTIVE ACTION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE PRODUCT DISTRIBUTOR HAS NOTIFIED INPECO THAT A SAMPLE TUBE OF A PATIENT ARRIVED AT THE HOSPITAL FOR AN HEMORRHAGIC SHOCK WAS LOADED ON THE AUTOMATION SYSTEM ON (B)(6) 2019. THE CUSTOMER REPORTED THAT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640836 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM CEM INPECO SA AP2 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death