BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 7669194 · Received July 9, 2018

    Report

    Report Number
    2432235-2018-00286
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    June 15, 2018
    Report Date
    July 9, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    UDI-DI
    00630414560045
    PMA / PMN Number
    K162977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER AND REPORTED THAT THERE WAS NO RINSING NEEDLE IN THE SAMPLING MODE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE SWAPPED VACUUM MEASURE ON THE PNEUMATIC BOARD AND DETERMINED THAT THERE WAS NO UNIFIED FLUIDS CIRCUIT (UFC) VACUUM. THE CSE REPLACED THE UFC, COMPRESSOR HEADS, COMPRESSOR TUBING, VACCUSHIELD AND HYDROPHOBIC FILTER, WASTE MANIFOLD, AND TUBINGS. THE CSE TESTED CONNECTORS ON THE PNEUMATIC CHASSIS AND RAN QUALITY CONTROLS, RECOVERING ACCEPTABLY. THE CSE REPORTED THAT HE WAS SPLASHED WITH BLEACH WHEN HE PUSHED BLEACH THROUGH THE UFC LIQUID SEPARATOR CHAMBER TO UFC WASTE LINE TO UNCLOG THE UFC PATHWAY. THE CSE REPORTED THAT HE WAS WEARING PROTECTION GLASSES. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING THE CLOGGED UNIFIED FLUIDS CIRCUIT (UFC) PATHWAY ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SPLASHED IN THE EYE WITH BLEACH. THE CSE RINSED HIS EYE WITH WATER AND DID NOT SEEK ADDITIONAL MEDICAL INTERVENTION OR TREATMENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE BLEACH THAT SPLASHED INTO THE CSE'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513166 ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER 00630414560045

    Patients

    Seq Age Sex Outcome Treatment
    1