BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FP KIT VI CELL XR QUAD PAK

    MDR report key: 2061539 · Received April 18, 2011

    Report

    Report Number
    1061932-2011-00275
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LDT
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR LABORATORY USE ONLY. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR LEAK IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ONE OF THE QUAD PACKS HAD LEAKED TRYPAN BLUE. CUSTOMER STATED IT APPEARS THE CAP HAD LEAKED AND WAS NOT PROPERLY SEALED (CAP WAS NOT INSTALLED CORRECTLY). THE VI-CELL PACKS WERE ENCLOSED IN PLASTIC BAGS. NO DEATH OR INJURY TO THE OPERATOR AS A RESULT OF THIS INCIDENT. THE OPERATOR WAS WEARING NITRILE GLOVES, LAB COAT AND GOGGLES. NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FP KIT VI CELL XR QUAD PAK VI-CELL XR (EXTENDED RANGE) COMPLETE SYSTEM LDT BECKMAN COULTER INC. XR QUAD PAK 3199182K

    Patients

    Seq Age Sex Outcome Treatment
    1