BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750 SLIDESTAINER

    MDR report key: 2181813 · Received July 28, 2011

    Report

    Report Number
    1061932-2011-01038
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    CLAS1 EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) CONFIGURED THE TUBING IN THE LIQUID TRAY AND REPLACED THE FILL AND DRAIN TUBE ASSEMBLY.FSE REPLACED ALL THE PERISTALTIC PUMPS.THE ROOT CAUSE OF THE STAIN LEAK IS DUE TO WORN OUT TUBING INSIDE THE PERISTALTIC PUMP.(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) CALL CENTER TO REPORT A STAIN LEAK IN THE CATCH TRAY OF THEIR LH750 SLIDESTAINER. THE OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (COAT, GLOVES, AND EYE PROTECTION) WHEN THE LEAK WAS DISCOVERED. NO INJURIES, MEDICAL ATTENTION OR EXPOSURE TO SKIN, OPEN WOUNDS OR MUCOUS MEMBRANES WAS REPORTED. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS CF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 SLIDESTAINER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH750 SS1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1