BEUDAMED
    FDA Adverse Event Summary report: N

    PLUMSET-DUAL W/CON PP, CAP PORT AND CLAVE

    MDR report key: 1041346 · Received May 12, 2008

    Report

    Report Number
    9615050-2008-00132
    Date Received
    May 12, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 22, 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
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DEVICE BREAKAGE; SUBSEQUENTLY, A LEAK OF A CHEMOTHERAPEUTIC AGENT WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF ETOPOSIDE. IT WAS REPORTED THAT WHILE THE NURSE WAS ATTACHING AN UNSPECIFIED SECONDARY TUBING SET TO THE CLAVE SECONDARY PORT ON THE CASSETTE, THE FLEXIBLE TUBING BETWEEN THE CLAVE SECONDARY PORT AND THE CASSETTE TORE. THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED AMOUNT OF SOLUTION LEAKED. THE SOLUTION THAT LEAKED 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 ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET-DUAL W/CON PP, CAP PORT AND CLAVE 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR