BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER

    MDR report key: 7052111 · Received November 22, 2017

    Report

    Report Number
    2432235-2017-00621
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    November 6, 2017
    Report Date
    January 5, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K162977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) FILED THE INITIAL MDR 2432235-2017-00621 ON 22-NOV-2017. ADDITIONAL INFORMATION (15-DEC-2017): UPON FURTHER INVESTIGATION, A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST DETERMINED THAT THE OPERATOR WAS PRIMING THE DRAIN/RINSE ON THE ADVIA 2120 HEMATOLOGY SYSTEM WHEN A TUBE WAS NOT PROPERLY PLACED ON THE SYSTEM. WHEN THE TUBE LOOSENED, THE OPERATOR WAS SPLASHED WITH THE ADVIA SHEATH/RINSE SOLUTION. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS SYSTEM IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S EYE WAS SPLASHED WITH ADVIA SHEATH/RINSE SOLUTION WHILE PRIMING THE DRAIN/RINSE ON THE ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER. ADVIA 120 / 2120 / 2120I HEMATOLOGY SYSTEMS OPERATOR'S GUIDE STATES THAT "ALL PRODUCTS OR OBJECTS THAT COME IN CONTACT WITH HUMAN OR ANIMAL BODY FLUIDS SHOULD BE HANDLED, BEFORE AND AFTER CLEANING, AS IF CAPABLE OF TRANSMITTING INFECTIOUS DISEASES. WEAR FACIAL PROTECTION, GLOVES, AND PROTECTIVE CLOTHING." THE CUSTOMER'S EYE WAS SPLASHED WITH ADVIA SHEATH/RINSE SOLUTION BECAUSE THE CUSTOMER DID NOT WEAR PERSONAL PROTECTIVE EQUIPMENT WHEN PRIMING THE DRAIN/RINSE. THE CAUSE OF THE EVENT IS USER ERROR.

    Description of Event or Problem · 1

    WHILE PERFORMING A TROUBLESHOOTING PROCESS ON THE ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER, A CUSTOMER'S EYE WAS SPLASHED WITH ADVIA SHEATH/RINSE SOLUTION (PRODUCT CODE: 01554628). THE CUSTOMER WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT WHEN PRIMING THE DRAIN/RINSE AND ACCIDENTLY RELEASED A TUBE, WHICH EXPOSED THE CUSTOMER'S EYE TO THE ADVIA SHEATH/RINSE SOLUTION. THE CUSTOMER WASHED HER EYE WITH WATER FOR 5 MINUTES. MEDICAL INTERVENTION WAS NOT REQUIRED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE LIQUID THAT SPLASHED INTO THE CUSTOMER'S EYE AND THERE WERE NO REPORTS OF IMPACT TO PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833129 ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1