BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3163518 · Received June 11, 2013

    Report

    Report Number
    1061932-2013-01107
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT TUBING WAS DISCONNECTED AT THE UPPER SHEATH TANK THAT LEAKED ONTO THE CONNECTORS AND SENSOR DISTRIBUTION CARD SHORTING IT OUT. THE FSE REPLACED THE DISCONNECTED TUBING THAT FIXED THE LEAK, AND CLEANED UP THE CONNECTORS AND SENSORS THAT FIXED THE ERROR MESSAGES. FAILURE MODE WAS DISCONNECTED TUBING AT THE UPPER SHEATH TANK. (B)(4). CUSTOMER TELEPHONE NUMBER: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE COULTER LH 780 HEMATOLOGY ANALYZER LEAKED A LIQUID AND GENERATED PROBE WIPE ERROR/DIL 1 CARD 15V ERROR. THE VOLUME OF THE LEAK IS UNKNOWN AND IT WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER POWERED DOWN THE ANALYZER. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LABORATORY COAT AND GLOVES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264407 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1