BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACS:180 SE

    MDR report key: 603438 · Received May 16, 2005

    Report

    Report Number
    2432235-2005-00009
    Event Type
    Other
    Date Received
    May 16, 2005
    Date of Event
    April 24, 2005
    Report Date
    April 25, 2005
    Manufacturer
    KMC SYSTEMS INC.
    Product Code
    LCI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2005 BAYER RECEIVED A REPORT OF A CUSTOMER WHO GOT A METAL SPLINTER WHILE TROUBLESHOOTING AN ACS:180 INSTRUMENT. A USER OF THE ACS: 180 WAS PERFORMING A CLEANING PROCEDURE WHEN THEY RECIEVED A VACCUL LOW ERROR FROM THIS PATIENT. IN AN EFFORT TO TROUBLESHOOT THE PROBLEM AND FOLLOWING INSTRUCTIONS FOR USE, THE CUSTOMER CHECKED THE SEALS ON THE WASTER CONTAINER ADND CHECKED THE WATER TRAP FOR FLUID, THE TRAP HAD FLUID, THE TRAP HAD FLUID. CUSTOMER REMOVED ADN CLEANED THE WATER TRAP AND RESTALLED IT. WHILE ATTEMPTING TO TIGHTEN THE CAP TO THE WATER TRAP A BRASS FILING FROM THE FITTING PENETRATED THEIR FINGER. CUSTOMER HAD THE FILING REMOVED IMMEDIATELY AND SOUGHT MEDICAL ATTENTION. THIS EVENT HAPPENED IN A BIOHAZARDOUS ENVIRONMENT AND THERE IS A POTENTIAL OF BIOHAZARD EXPOSURE FOR THAT REASON IT IS BEING REPORTED. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS:180 SE IMMUNOASSAY SYSTEM LCI KMC SYSTEMS INC. ACS:180 SE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other