BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH SLIDE STAINER

    MDR report key: 2247439 · Received September 14, 2011

    Report

    Report Number
    1061932-2011-01444
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GHK
    PMA / PMN Number
    EXEMPT
    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) REPLACED THE FILL AND DRAIN TUBING TO BATH TWO AND REPLACED THE WASTE FILTER. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER COMPLETION OF VERIFIED REPAIRS. THE ROOT CAUSE OF THE LEAKS WERE ULTIMATELY ATTRIBUTED TO A DAMAGED SENSOR MECHANISM AND A PLUG IN THE STAIN FILL TUBE. MDRS ASSOCIATED WITH THIS EVENT: 1061932-2011-01445, 1061932-2011-01444.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THEY HAD OBSERVED A LEAK ON A LH SLIDE STAINER ON TWO DIFFERENT DAYS. THIS IS REPORT ONE OF TWO AND REPRESENTS THE LH SLIDE STAINER LEAK OBSERVED ON (B)(6) 2011 INITIALLY, THE CUSTOMER HAD INDICATED THAT THE LEAK HAD NOT CAUSED AN OVERFLOW OF THE LH SLIDE STAINER OVERFLOW TRAYS. HOWEVER, A BECKMAN COULTER INC. FIELD SERVICE ENGINEER WHILE ON SITE TO ADDRESS THE LH SLIDE STAINER LEAK, INDICATED THAT THE CUSTOMER HAD REPORTED THAT THE LH SLIDE STAINER BATH NUMBER TWO HAD LEAKED AND HAD OVERFLOWED THE INSTRUMENT TRAYS. 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. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. 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 LH SLIDE STAINER SLIDE STAINER, AUTOMATED GHK BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1