BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    MDR report key: 3103411 · Received May 9, 2013

    Report

    Report Number
    1061932-2013-00770
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 FOUND TUBING LOOSE ON RETIC WASTE CHAMBER (VC26) WHICH WAS CAUSING A LEAK OF DILUTED RETIC STAIN REAGENT. THE FSE REPLACED THE TUBING RESOLVING THE LEAK. THE FSE REPLACED THE BLOOD/STAIN ASPIRATION PUMP (PM11) TO RESOLVE THE RETIC VOTE OUT ISSUE. THE FSE COULD NOT REPRODUCE THE PLATELET (PLT) BACKGROUND FAILURES; HOWEVER, THE ISSUE WAS RESOLVED THROUGH THE SERVICE. SERVICE ACTIVITY WAS PERFORMED AND WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. FAILURE MODE WAS RELATED TO LOOSE TUBING ON VC26 AND A DEFECTIVE PM. HOWEVER, THE INSTRUMENT GENERATED RETIC VOTE OUTS AND PLT BACKGROUND FAILURES ALERTING THE OPERATOR OF AN INSTRUMENT ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT <50 ML OF CLENZ WAS LEAKING FROM THE COULTER LH 750 HEMATOLOGY ANALYZER, FROM AN UNKNOWN SOURCE, WITH AN INTERMITTENT PLATELET (PLT) BACKGROUND FAILURES (2FL SPIKES) AND RETIC VOTE OUTS. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203821 COULTER® LH 750 HEMATOLOGY ANALYXZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1