BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDLAB 1265 BLOOD GAS SYSTEM

    MDR report key: 1030834 · Received April 17, 2008

    Report

    Report Number
    1217157-2008-00001
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    February 29, 2008
    Report Date
    April 11, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
    Product Code
    CHL
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED): A FIELD APPLICATION SPECIALIST REMAINED AT THE SITE FOR MANY DAYS. THERE WERE NO FURTHER PROBLEMS WITH THE INSTRUMENT. (LUER VALVE): IF THE SAMPLE PORT IS NOT ATTACHED CORRECTLY, IT CAN FORCE THE PROBE TO EXIT THE CARTRIDGE AT AN ANGLE. THE PROBE MAY THEN 'CATCH' ON THE EDGE OF THE SYRINGE LUER AND EJECT IT FROM THE INSTRUMENT. CONCLUSIONS: (USER ERROR CAUSED EVENT). THIS EVENT IS BEING REPORTED BECAUSE IT OCCURRED IN A POTENTIALLY BIOHAZARDOUS ENVIRONMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A NURSE WAS ANALYZING A SAMPLE ON THE INSTRUMENT AND AFTER 3-4 SECONDS AFTER PRESSING THE ANALYZE BUTTON ON THE INSTRUMENT, THE SYRINGE WAS EJECTED FROM THE SAMPLE ENTRY AND BLOOD WAS SPLATTERED ON HER FACE. CUSTOMER STATES THAT THEY CHECKED THE INSTRUMENT FLUIDIC SYSTEM THROUGH AND NO PROBLEMS WERE FOUND. THE CUSTOMER STATED THAT THE CARTRIDGES AND THE MANIFOLD WERE CHANGED TO ENSURE THEY WERE NOT THE CAUSE OF THE PROBLEM. THE PT SAMPLE INVOLVED WAS TESTED AND ALL RESULTS WERE NEGATIVE. THE NURSE DID NOT UNDERGO ANY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLAB 1265 BLOOD GAS SYSTEM RAPIDLAB 1265 CHL SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. RL1265 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK