BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 1972076 · Received January 27, 2011

    Report

    Report Number
    1061932-2011-00047
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    CL1 EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE RED STRIP TUBING ATTACHED TO THE DISPENSE PROBE WAS SPLIT AND DID NOT HAVE SPARE TUBING. A BCI FIELD SERVICE ENGINEER (FSE) REPORTED THE LOWER TRAYS ON THE SLIDE MAKER WERE FILLED WITH DILUENT AND BLOOD. THE ACTUATOR PANEL WAS ALSO FLOODED. THE FSE REPLACED TUBING THAT SHOWED WEAR AND FAILURE, DECONTAMINATED SLIDE MAKER, AND CLEANED UP THE LOWER TRAYS AND INTERNAL COMPARTMENTS WITH BLEACH SOLUTION. THE SMEAR TRUCK WAS ALIGNED AND FULL OPERATION OF SLIDE MAKER WAS CHECKED. NO ISSUE WAS FOUND. THE ROOT CAUSE FOR THE EVENT WAS WEAR AND FAILURE OF MULTIPLE SLIDE MAKER TUBINGS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A BLOODY LEAK LOCATED AROUND THE DISPENSE PROBE OF COULTER LH750 SLIDEMAKER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND CLEANED THE SPILL WITH THE APPROPRIATE DISINFECTANT. THE FACILITY HAS AN EXPOSURE PLAN. MSDS WAS NOT REVIEWED. THERE WAS NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANES, EYES, MOUTH, OR OPEN LESIONS. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 SLIDEMAKER AUTOMATED SLIDE SPINNER GKJ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1