BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CA-1500 ANALYZER

    MDR report key: 2992502 · Received March 4, 2013

    Report

    Report Number
    1422681-2013-00005
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 3, 2013
    Manufacturer
    SYSMEX CORP
    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

    NO MALFUNCTION OF THE SYSMEX CA-1500 ANALYZER WAS REPORTED. THE FSE WAS SERVICING THE ANALYZER AND IT WAS NOT IN OPERATION AT THE TIME OF THE EVENT. A REVIEW OF THE SYSMEX CA-1500 SERIES INSTRUCTIONS FOR USE INCLUDES NUMEROUS WARNINGS REGARDING SAFE HANDLING OF THE SAMPLE PROBE. A USER IS ADVISED TO HANDLE ALL INSTRUMENTS PARTS AS BIOLOGICALLY HAZARDOUS, TO WEAR GLOVES WHILE HANDLING THE PROBES AND TO WASH HANDS WITH DISINFECTANT AFTER CLEANING. WHEN CLEANING, THE PROBE SHOULD BE HANDLED FROM TOP TO BOTTOM TO PREVENT PIERCING A FINGER. A USER ALSO IS WARNED THAT THE PIERCER IS EXTREMELY SHARP AND DANGEROUS AND THAT THE USED PIERCER BE DISCARDED IN A SAFE PLACE TO PREVENT STICK INJURY. CURRENT STATUS OF THE FSE IS NOT KNOWN. THIS OCCURRENCE IS REPORTED IN REGARD TO THE (B)(4) NEEDLE-STICK MEDICAL DEVICE REPORTING GUIDELINE, AS ANTI-VIRAL POST-EXPOSURE PROPHYLAXIS WAS ADMINISTERED IN ADDITION TO FIRST AID. NONE OF THE COMPLAINT NARRATIVE STATES OR IMPLIES THAT THE DEVICE FAILED IN ANY WAY. SPECIFIC CORRECTIVE ACTION ON THE INSTRUMENT, OTHER THAN REPLACEMENT OF THE SAMPLE PROBE, IS NOT KNOWN.

    Description of Event or Problem · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS FIELD SERVICE ENGINEER, WHO WAS REPLACING THE SAMPLE PROBE OF A SYSMEX CA-1500 ANALYZER, SERIAL NUMBER (B)(4), WAS STUCK BY THE SAMPLE NEEDLE WHILE DISPOSING OF THE PART. HIS SKIN WAS PUNCTURED AND HE SUFFERED POTENTIAL EXPOSURE TO BLOOD-BORNE PATHOGENS. IT IS NOT KNOWN IF HE WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE), SUCH AS GLOVES, AT THE TIME. THE FSE WAS TREATED AT THE ER AND GIVEN ANTI-VIRAL PROPHYLAXIS. IT IS NOT KNOWN IF THE FSE OR ANY POTENTIAL SOURCE PTS WERE TESTED FOR EXPOSURE TO BLOOD-BORNE PATHOGENS. THE EVENT OCCURRED IN (B)(6) AND WAS REPORTED TO SYSMEX CORP (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91587 SYSMEX CA-1500 ANALYZER AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORP CA-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention