BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 7044899 · Received November 20, 2017

    Report

    Report Number
    1061932-2017-00019
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 1, 2017
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590192242
    PMA / PMN Number
    K120771
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT SCHEDULED FOR THE CUSTOMER SITE, THE LABORATORY'S BIOMEDICAL ENGINEER WAS IN THE PROCESS OF CORRECTING THE DRAIN ISSUE WHEN THE EVENT OCCURED. THE CAUSE OF THE LEAK WAS DUE TO A LOOSE FITTING ON THE DXH 600 WASTE LINE TO THE FLOOR DRAIN. THE CUSTOMER WAS SPLASHED IN THE FACE AND EYES WHILE ATTEMPTING TO CHANGE A FITTING WITH NO FACE PROTECTION, AS A RESULT THE CUSTOMER WAS EXPOSED TO BIOHAZARDOUS FLUID. PER UNICEL DXH SERIES WITH SYSTEM MANAGER B26647, REV AE, BECKMAN COULTER INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOSPITAL'S BIOMEDICAL ENGINEER WAS SPRAYED IN THE FACE AND EYES WITH AN UNKNOWN VOLUME OF WASTE FLUID FROM THE DXH 600 INSTRUMENT. PER PHONE CONVERSATION ON (B)(6) 2017 THE CUSTOMER CONFIRMED THERE WAS A LEAK DUE TO A LOOSE FITTING ON THE INSTRUMENT WASTE LINE TO THE FLOOR DRAIN AT THE TIME OF THE EVENT. THE CUSTOMER STATED THAT THE UNIT WAS NOT OPERATIONAL WHILE ATTEMPTING TO CHANGE A FITTING. THE BIOMEDICAL ENGINEER WAS SPLASHED WITH A MIXTURE CONSISTING OF BLOOD AND REAGENTS ON BOARD THE INSTRUMENT AND WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES WITH NO EYE PROTECTION WHILE ATTEMPTING TO CHANGE THE FITTING ON THE WASTE LINE. PER SUBMITTER THE SITE'S EXPOSURE PLAN WAS IMMEDIATELY PLACED INTO EFFECT AT THE TIME OF THE INCIDENT. THE CUSTOMER SOUGHT MEDICAL ATTENTION ON (B)(6) 2017 BY GOING TO THE EMERGENCY ROOM. THE CUSTOMER CONFIRMED THEY WERE NOT ADMITTED TO THE HOSPITAL BUT WAS ADMINISTERED DECONTAMINATION TREATMENT WHICH INCLUDED RINSING OF THE EYES FOR ONE HOUR. THE EYE RINSE WAS IMMEDIATELY FOLLOWED BY POST-EXPOSURE PROPHYLAXIS ANTIRETROVIRAL MEDICATION. THE CUSTOMER ALSO STATED FOLLOW UP BLOOD TESTS WILL BE PERFORMED BY THE FACILITY'S EMPLOYEE HEALTH NURSE. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825823 UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A 15099590192242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other