BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PUMP SET WITH 0.2MICRON FILTER AND PA-ASV

    MDR report key: 1190724 · Received October 6, 2008

    Report

    Report Number
    9615050-2008-00289
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K023062
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF 5FU. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT SOLUTION LEAKED AROUND THE FILTER OF THE TUBING SET. THE SPILL WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR PUMP SET WITH 0.2MICRON FILTER AND PA-ASV 80-FRN FRN HOSPIRA DE COSTA RICA LTD. NA 630425H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK