BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX XE-5000 ANALYZER

    MDR report key: 4368896 · Received December 8, 2014

    Report

    Report Number
    3009711478-2014-00025
    Event Type
    Injury
    Date Received
    December 8, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 18, 2014
    Manufacturer
    SYSMEX CORP
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIOUS INJURY OR A SERIOUS DETERIORATION IN THE STATE OF HLTH IS A REMOTE POSSIBILITY WERE THIS ISSUE TO RECUR. THE -0/04 MPA ERROR AND THE PRESENCE OF FLUID IN THE TRAP CHAMBER INDICATE THAT A MALFUNCTION OCCURRED. A SYSMEX REP CONFIRMED WITH A MEMBER OF THE EXPOSURE HOTLINE THAT FOLLOW UP TESTING OF THE USER INJURED WILL BE PERFORMED; HOWEVER, NO OTHER INFO WOULD BE RELEASED, CITING HLTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) REQUIREMENTS RESTRICTING RELEASE OF MED INFO WITHOUT THE PT'S CONSENT. THE USER DID NOT RECEIVE STITCHES, BUT IT IS NOT KNOWN IF EXPOSURE TO BLOOD-BORNE PATHOGENS OCCURRED AND IF ANTI-VIRAL PROPHYLAXIS WAS ADMINISTERED AS A PRECAUTION. THIS INCIDENT WILL BE REPORTED AS THE OPERATOR ENDURED INJURY TO A FINGER THAT MAY HAVE RESULTED IN EXPOSURE REQUIRING PERIODIC, FOLLOW-UP TESTING TO BE PERFORMED.

    Description of Event or Problem · 1

    THE USER SUFFERED A CUT TO HIS FINGER WHEN ATTEMPTING TO REMOVE THE PNEUMATIC UNIT TRAP CHAMBER. HE NOTICED AN -0.04 MPA ERROR OCCURRED AND THE ANALYZER WENT INTO A "NOT READY" STATE. THE USER FOUND THAT THE CHAMBER WAS FILLED WITH FLUID BECAUSE OF A MALFUNCTION. THE USER PUT THE ANALYZER INTO SHUT DOWN AND TURNED OFF THE POWER. THE CHAMBER WAS VERY TIGHT AND WHEN THE USER PUT ADDITIONAL PRESSURE ON THE PART TO REMOVE IT, THE CHAMBER BROKE, LEAVING A SHARP EDGE THAT CUT HIS FINGER. THE WOUND WAS DEEP AND APPROXIMATELY ONE INCH LONG. IT IS NOT KNOWN IF THE USER WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE), SUCH AS GLOVES, LAB COAT, ETC., AT THE TIME OF THE EVENT. THE USER CAUSED THE WOUND TO BLEED. THE WOUND WAS RINSED AND WHEN THE BLEEDING STOPPED, AN ANTI-BIOTIC OINTMENT AND BANDAGE WERE APPLIED BY THE OPERATOR TO HIS FINGER. THE EMPLOYEE HLTH DEPARTMENT WAS CONTACTED TO REPORT THE INCIDENT. THE USER WAS NOT TREATED IN THE EMERGENCY ROOM AND NO STITCHES WERE APPLIED TO THE WOUND. A REP FROM THE EXPOSURE CONTROL HOTLINE SAID THE USER WILL BE MONITORED FOR CLINICAL STATUS WITH BASE, SIX-WEEK, THREE-MONTH AND SIX-MONTH SAMPLES TAKEN FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789540 SYSMEX XE-5000 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORP XE-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other