BEUDAMED
    FDA Adverse Event Death Summary report: N

    APTIO AUTOMATION

    MDR report key: 8901772 · Received August 16, 2019

    Report

    Report Number
    3007494875-2019-00001
    Event Type
    Death
    Date Received
    August 16, 2019
    Date of Event
    July 23, 2019
    Report Date
    September 13, 2019
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172342008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    SIEMENS FILED THE INITIAL MDR 3007494875-2019-00001 ON 16-AUGUST-2019. ADDITIONAL INFORMATION (22-AUGUST-2019): THE CUSTOMER INFORMS THAT NOVOSEVEN TREATMENT WAS DELAYED. SIEMENS PERFORMED A FOLLOW-UP WITH THE CUSTOMER, AND THE CUSTOMER PROVIDES NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THERE WAS A DELAY IN TREATMENT ADMINISTRATION FOR A PATIENT BECAUSE THERE WAS A DELAY IN OBTAINING HEMOSTASIS TEST RESULTS (PROTHROMBIN TIME, ACTIVATED PARTIAL THROMBIN TIME, AND FIBRINOGEN) ON A PATIENT SAMPLE DUE TO THE APTIO AUTOMATION SYSTEM. BASED ON THE DATA PROVIDED BY THE CUSTOMER, IT IS SIEMENS UNDERSTANDING THAT THE SAMPLE TUBE (ID #(B)(6)) WAS LOADED ON THE APTIO AUTOMATION SYSTEM (SERIAL NUMBER: (B)(4)), ON (B)(6) 2019, FOR CENTRIFUGATION AND SORTING. THE OPERATOR INDICATED THAT THE SAMPLE TUBE DIVERTED TO THE CENTRIFUGE MODULE (CM) AT 3:10 A.M. AND THE AUTOMATION SYSTEM PRODUCED AN ERROR CODE "06B0" AND A MESSAGE "SAFETY SHIELD OPEN" DURING THE SAMPLE PROCESSING AT 3:27 A.M. BASED ON SIEMENS UNDERSTANDING, THE SAMPLE WAS SCHEDULED TO RUN TEST METHODS (PROTHROMBIN TIME, ACTIVATED PARTIAL THROMBOPLASTIN TIME, AND FIBRINOGEN) ON A NON-SIEMENS ANALYZER THAT IS NOT INTERFACED TO THE AUTOMATION SYSTEM. THE CUSTOMER STATED THAT THE SAMPLE TUBE (ID #(B)(6)) WAS AN EMERGENCY TUBE, BUT IT WAS NOT CLASSIFIED AS A STAT SAMPLE. THE CUSTOMER INDICATED THAT THE PATIENT RESULT(S) WERE RELEASED TO THE PHYSICIAN(S) AT 4:30 A.M. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED AT 4:40 A.M. ON (B)(6) 2019. SIEMENS EVALUATED THE LOG FILES AND IDENTIFIED THE ERROR MESSAGE "SAFETY SHIELD OPEN", DISPLAYED ON THE USER INTERFACE AT 3:27 A.M., AND WAS NOT CLEARED/RESET FOR 23 MINUTES. IT IS SIEMENS UNDERSTANDING THAT AT 3:50 A.M. THE CENTRIFUGE MODULE (CM) RETURNED TO NORMAL, AND THE PATIENT SAMPLE TUBE RETURNED TO THE AUTOMATION TRACK AND WAS SENT TO THE INPUT/OUTPUT MODULE (IOM) AT 3:53 A.M. FOR THE CUSTOMER TO LOAD IT ON A NON-SIEMENS ANALYZER. SIEMENS CONFIRMED THE USER IS TRAINED TO USE THE AUTOMATION SYSTEM, AND AWARE OF THE ERROR CONDITION THAT DISPLAYED ON THE USER INTERFACE. THE OPERATOR COMPLETED THE ERROR RECOVERY, AND THE AUTOMATION SYSTEM WAS OPERATIONAL. THE AUTOMATION SYSTEM AT THE CUSTOMER SITE IS FUNCTIONING WITHOUT ISSUE, AND THERE IS NO NEEDED FOR SERVICE OR MAINTENANCE. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED. THIS MDR PERTAINS TO THE SAME PATIENT REFERENCED IN MDR 2432235-2019-00252, AND THE MANUFACTURER (INPECO) FILED MDR 3010825766-2019-00008 FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695561 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM CEM INPECO SA AP2 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death