BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 SLIDEMAKER ANALYZER

    MDR report key: 2133177 · Received June 20, 2011

    Report

    Report Number
    1061932-2011-00710
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND FOUND THE LEAK AT THE TUBING ON THE PERISTALTIC PUMP 1 AND REPLACED THE BATH 1 PERISTALTIC PUMP AND TUBING. THE FSE VERIFIED THE INSTRUMENTS OPERATION. THE ROOT CAUSE WAS ATTRIBUTED TO A LEAK FROM THE TUBING ASSOCIATED WITH THE BATH 1 PERISTALTIC PUMP. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE CUSTOMER FOUND FLUID IN THE TUBING TRAY ON THE COULTER LH 750 SLIDEMAKER ANALYZER. PER THE CUSTOMER, THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND APPEARED TO BE METHANOL REAGENT FROM THE SPLIT TUBING ON THE PUMP 1 FOR BATH 1. THE CUSTOMER DOES NOT HAVE A SPARE PUMP AND REQUESTED INSTRUMENT SERVICE. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 SLIDEMAKER ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1