BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® PREPPLUS

    MDR report key: 2242332 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01411
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE CHECKED THE PREPPLUS AND TESTED DIFFERENT TUBES. NO TECHNICAL PROBLEMS WERE FOUND. ROOT CAUSE OF EVENT IS DUE TO THE CUSTOMER USING SAMPLE TUBES THAT WERE NOT VALIDATED FOR THE PREPPLUS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEIR COULTER PREPPLUS WAS MAKING BLOOD DROPS AND SPLASHES IN FRONT OF THE INSTRUMENT. THIS ISSUE OCCURS ONLY WHEN THE CUSTOMER USES BECTON DICKINSON (BD) VACUTAINER REF. (B)(4) (LITHIUM-HEPARIN) AND REF. (B)(4) (SODIUM-HEPARIN) AND NOT WITH TRUMO VENOSAFE TUBES REF. (B)(4). THESE TUBES ARE FROM BD BUT NOT LISTED IN THE LABELING. LABELING INSTRUCTS THE USER TO TEST UNLISTED TUBES FOR ACCEPTABLE USE WITH THE PREPPLUS AND THE LABORATORY'S APPLICATION. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® PREPPLUS PIPETTING AND DILUTING SYSTEM FOR CLINICAL USE JQW BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1