BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PLUMSET-OL DUAL W/CLAVE & 0.2 MICRON FILTER

    MDR report key: 1052468 · Received May 22, 2008

    Report

    Report Number
    9615050-2008-00149
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 29, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS EVALUATED. TESTING FOUND THE TUBING HAD SEPARATED FROM THE FILTER. THIS WAS DUE TO INSUFFICIENT SOLVENT APPLICATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. PRIOR TO PT USE WHILE PRIMING THE TUBING WITH SALINE, THE TUBING SEPARATED FROM THE DISTAL FILTER CONNECTION. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS PLUMSET-OL DUAL W/CLAVE & 0.2 MICRON FILTER 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA 590925H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA