BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 (SLIDER MAKER ) HEMATOLOGY ANALYZER

    MDR report key: 2242293 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01433
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THE LEAK OCCURRED DURING THE SHUT DOWN PROCEDURE AND THAT THE TUBING ABOVE THE RESERVOIR IN THE DILUTER MODULE HAD A PIN-HOLE LEAK THAT WOULD NOT FULLY EVACUATE THE CHAMBER OF THE SLIDEMAKER DURING THE CLEANING CYCLE. UPON REFILL, THE CHAMBER WOULD FORCE THE EXCESS FLUID THROUGH THE VENT LINE AND ONTO THE TRAY. SEVERAL SECTIONS OF TUBING WERE AFFECTED BY THE FORCE OF THE EXCESS FLUID FORCED THROUGH THEM AND NEEDED TO BE REPLACED. FSE REPLACED ALL THE BROWN STRIPE TUBING IN THE DILUTER MODULE ON THE LEFT SIDE OF UNIT. THE REPAIR WAS VERIFIED AS PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE FOR THE LEAK IS A PIN-HOLE IN VACUUM TUBING ABOVE RESERVOIR IN THE DILUTER THAT CONNECTS TO THE SLIDE-MAKER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT EVIDENCE OF A SMALL CLENZ LEAK IN THE TRAYS OF THE LH750 SLIDEMAKER WHEN THEY CLEANED THEM. THE CUSTOMER WAS UNABLE TO LOCATE THE SOURCE OF THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED; HOWEVER, IT IS READILY AVAILABLE. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT. NO IMPACT TO SAMPLE RESULTS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 (SLIDER MAKER ) HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH750 SM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1