BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ® LH750

    MDR report key: 1973070 · Received January 28, 2011

    Report

    Report Number
    1061932-2011-00050
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED TUBING IN VL57A AND VL13 AND BLEACHED THE BELLOWS DRAIN PATH THRU VL57. NO FLUID WAS SEEN AFTER REPAIRS WERE CONCLUDED. PER FSE, THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND DRIP TRAYS. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED TUBING IN VL57A AND VL13 AND BLEACHED THE BELLOWS DRAIN PATH THRU VL57. NO FLUID WAS SEEN AFTER REPAIRS WERE CONCLUDED. PER FSE, THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND DRIP TRAYS. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A BLOOD LEAK ON TOP OF THE NEEDLE BELLOWS AND ON THE TUBE STOPPER ON COULTER LH 780 HEMATOLOGY ANALYTICAL PACKAGING STATION. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A BLOOD LEAK ON TOP OF THE NEEDLE BELLOWS AND ON THE TUBE STOPPER ON COULTER LH 750 HEMATOLOGY ANALYTICAL PACKAGING STATION. 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 LH750 HEMATOLOGY ANALYTICAL STATION, PKG GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1