BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT¿ 5DIFF CAP PIERCE (CP)

    MDR report key: 2250556 · Received September 16, 2011

    Report

    Report Number
    1061932-2011-01474
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE REAGENT SYRINGE BLOCK HAD A CRACK AT THE HEMOGLOBIN LYSE SYRINGE. THE FSE REPLACED THE LEAKING REAGENT SYRINGE. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER COMPLETION OF VERIFIED REPAIRS. THE ROOT CAUSE FOR THIS EVENT IS ATTRIBUTED TO A CRACKED HGB LYSE SYRINGE

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THEY OBSERVED A HEMOGLOBIN (HGB) LYSE LEAK UNDERNEATH THE COULTER ACT 5DIFF CAP PIERCE (CP) INSTRUMENT. THE HEALTHCARE WORKERS INTERFACING WITH THE MACHINE WERE WEARING PERSONAL PROTECTIVE EQUIPMENT, WHICH INCLUDED LABORATORY COATS AND GLOVES, AT THE TIME OF OCCURRENCE THERE WAS NO BIOHAZARDOUS EXPOSURE TO HEALTHCARE WORKER UNCOVERED WOUNDS OR MUCOUS MEMBRANES AND NO INJURIES WERE REPORTED. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. BECKMAN COULTER INC. PERSONNEL REVIEWED CUSTOMER PATIENT DATA AND FOUND THAT NO PATIENT RESULTS WERE AFFECTED BY THE LEAK. THE LEAK WAS FOUND BEFORE THE START UP OF THE DAY AND THE CUSTOMER DID NOT RUN SAMPLES AFTER THE LEAK WAS FOUND. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS AN EXPOSURE PLAN IN PLACE AT THE FACILITY AND A MATERIAL SAFETY DATA SHEET WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT¿ 5DIFF CAP PIERCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1