BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX CA-650 COAGULATION ANALYZER

    MDR report key: 4369936 · Received December 8, 2014

    Report

    Report Number
    3009711478-2014-00024
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    September 28, 2014
    Report Date
    November 11, 2014
    Manufacturer
    SYSMEX CORP.
    Product Code
    GKP
    PMA / PMN Number
    K031377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE POTENTIAL EXISTS FOR USER EXPOSURE TO BLOOD-BORNE PATHOGENS. TREATMENT MAY HAVE INCLUDED ANTI-VIRAL POST-EXPOSURE PROPHYLAXIS. IT IS NOT KNOWN IF ANY TESTING FOR (B)(6) WAS ORDERED OR PERFORMED. THE DECISION TO REPORT THIS ISSUE WAS MADE BECAUSE IT IS UNKNOWN IF ANTI-VIRAL PROPHYLAXIS WAS CONSIDERED NECESSARY BY THE USER'S EMPLOYER. THE COMPLAINANT TEXT STATED THAT A PRODUCT MALFUNCTION OCCURRED. THE ANALYZER CONTRIBUTED TO THE EVENT REPORTED. WASTE FLUID LIKELY IS CONTAMINATED WITH BIO-HAZARDOUS MATERIAL THAT MAY CONTAIN BLOOD-BORNE PATHOGENS. NO EVIDENCE, SUCH AS AN ERROR LOG OR PHOTOGRAPHS WERE SUBMITTED TO ILLUSTRATE THAT AN ACTUAL DEVICE FAILURE OCCURRED OR IF THE FLUID BEGAN TO LEAK BECAUSE A PIECE OF TUBING BECAME WORN AND SLIPPED OFF OF A CONNECTION. THIS INCIDENT IS AN ACCIDENTAL EXPOSURE. ANYONE PERFORMING MAINTENANCE ON EQUIPMENT IS REQUIRED TO FOLLOW ALL DIRECTIVE IN THE SYSMEX OPERATOR'S MANUALS AS WELL AS ANY OSHA REQUIREMENTS FOR PPE; HOWEVER, BECAUSE THE USER INCURRED AN EYE INJURY THAT HAD POTENTIAL FOR EXPOSURE TO BLOOD-BORNE PATHOGENS AND POTENTIALLY WAS GIVEN ANTI-VIRAL PROPHYLAXIS, THE INJURY IS CONSIDERED SERIOUS, AND CARE WOULD EXCEED SIMPLE FIRST-AID MEASURES.

    Description of Event or Problem · 1

    (B)(4) WAS CONNECTED ON (B)(6) 2014 REGARDING AN INCIDENT OF POSSIBLE EXPOSURE AFTER A MALFUNCTION OCCURRED AT OR NEAR THE SOLENOID VALVE OF A CA-650 AUTOMATED BLOOD COAGULATION ANALYZER (SERIAL NUMBER (B)(4)) IN (B)(6). OVERFLOW DEVELOPED FROM THE WASHING SPITZ DURING THE PIPETTE WASHING SEQUENCE AND LIQUID WASTE BEGAN TO ACCUMULATE IN THE TRASH BOX WHERE USED REACTION TUBES NORMALLY FALL. THE USER WAS SPLASHED IN THE EYE WITH FLUID CONTAINING CA CLEAN I, DETERGENT (A SOLUTION CONTAINING SODIUM HYPOCHLORITE), AND LIQUID WASTE WHEN THE DISPOSAL BOX WAS REMOVED TO DISCARD THE USED REACTION TUBES. THE ISSUE OCCURRED ON (B)(6) AND WAS REPORTED TO SYSMEX AMERICA, INC. (SAI) ON (B)(6). IT WAS NOT KNOWN IF THE TECHNOLOGIST FLUSHED HIS/HER EYES WITH WATER FOR AT LEAST 15 MINUTES AS DIRECTED IN THE INSTRUCTIONS FOR USE (IFU), BUT DID RECEIVE MEDICAL ATTENTION. THE USER'S EYES BECAME RED AND SWOLLEN, AND THE USER WAS GIVEN AN OPTHALMIC DROP TO USE IN THE EYES, THE REDNESS AND SWELLING SUBSIDED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792535 SYSMEX CA-650 COAGULATION ANALYZER AUTOMATED BLOOD COAGULATION ANALYZER GKP SYSMEX CORP. CA-650

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other