BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750 SLIDEMAKER

    MDR report key: 1973241 · Received January 28, 2011

    Report

    Report Number
    1061932-2011-00053
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Product Code
    GKZ
    PMA / PMN Number
    CLAS1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) DRAINED THE CHAMBER VC-2 AND REPLACED PINCH VALVE VL-36B. ROOT CAUSE FOR THIS EVENT IS A FILLED VACUUM CHAMBER AND/OR A DEFECTIVE PINCH VALVE VL-36B.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A BLOOD LEAK ON THE LEFT SIDE OF THE LH750 COULTER LH 750 SLIDEMAKER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (GOWN, GLOVES AND GOGGLES). NO CHANGE TO PATIENT TREATMENT, NO DEATH, SERIOUS INJURY, OR EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS BEEN REPORTED IN ASSOCIATION WITH THIS EVENT. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ® LH750 SLIDEMAKER HEMATOLOGY SLIDEMAKER GKZ LH 750 SLIDERMAKER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1