BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 2521969 · Received April 6, 2012

    Report

    Report Number
    1061932-2012-01136
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    March 10, 2012
    Report Date
    March 10, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED BROKEN PINCH VALVE VL33 TO RESOLVE PROBLEMS WITH RINSE CUP OVERFLOW AND LEAKING. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE LEAK WAS A BROKEN PINCH VALVE VL33. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A DILUTED BLOOD LEAK (LESS THAN 1CC) ON THE RIGHT SIDE OF THE RINSE CUP AGAINST THE WALL. THE LEAK STAYED CONTAINED INSIDE THEIR COULTER LH 750 SLIDEMAKER. THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLASSES AND GLOVES AT THE TIME OF THE INCIDENT. NO INJURY OR EXPOSURE WAS REPORTED. NO PATIENT SAMPLES WERE AFFECTED BY THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 SLIDEMAKER AUTOMATED SLIDE SPINNER GKJ BECKMAN COULTER INC. LH 750 SLIDEMAKER NA

    Patients

    Seq Age Sex Outcome Treatment
    1