BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CA-1500 ANALYZER

    MDR report key: 2930380 · Received January 22, 2013

    Report

    Report Number
    1422681-2013-00001
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 24, 2012
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKP
    PMA / PMN Number
    K993299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSMEX CA-1500 ANALYZER PERFORMED AS EXPECTED; NO MALFUNCTION WAS REPORTED. THE OPERATOR REACHED UNDER THE LIGHT SHIELD WHILE THE ANALYZER WAS IN OPERATION IN AN ATTEMPT TO ADD REAGENT. A REVIEW OF THE SYSMEX CA-1500 SERIES INSTRUCTIONS FOR USE INCLUDES SEVERAL USER WARNINGS TO NOT OPEN THE LIGHT SHIELD COVER DURING ANALYSIS. THIS COULD CAUSE INJURY. NONE OF THE COMPLAINT NARRATIVE STATES OR IMPLIES THAT THE DEVICE FAILED IN ANY WAY. CURRENT STATUS OF THE OPERATOR IS NOT KNOWN. SPECIFIC CORRECTIVE ACTION ON THE INSTRUMENT IS NOT KNOWN.

    Description of Event or Problem · 1

    AN INTERNAL INCIDENT REPORT WAS PREPARED AT A LABORATORY IN THE UNITED STATES AND SUBMITTED TO SIEMENS HEALTHCARE DIAGNOSTICS ON (B)(4) 2012 REGARDING THE OPERATOR OF A SYSMEX CA-1500 ANALYZER, SERIAL NUMBER (B)(4), WHO REACHED UNDER THE LIGHT SHIELD AND ATTEMPTED TO ADD REAGENT WHILE THE ANALYZER WAS IN OPERATION. HER HAND WAS STRUCK AND CUT BY THE MOVING REAGENT PROBE. THE PROBE BODY WAS CRACKED AND BROKEN BECAUSE OF THE IMPACT. IT IS NOT KNOWN IF SHE WAS WEARING APPROPRIATE PERSONNEL PROTECTIVE EQUIPMENT (PPE), SUCH AS GLOVES, AT THE TIME. THE OPERATOR WAS TREATED AT THE EMERGENCY ROOM AND WAS GIVEN ANTI-VIRAL PROPHYLAXIS. THE HAND WAS CLEANED. SHE WAS DRAWN FOR BASELINE CBC AND CHEMISTRY PROFILE. IT IS NOT KNOWN IF THE OPERATOR OR POTENTIAL SOURCE WAS TESTED FOR EXPOSURE TO BLOOD-BORNE PATHOGENS. THE OCCURRENCE WAS REPORTED TO SYSMEX CORPORATION (B)(4) ON (B)(4), 2012 AND RELAYED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31172 SYSMEX CA-1500 ANALYZER AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORPORATION CA-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention