BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET VENTED 100 X 60

    MDR report key: 1031459 · Received April 18, 2008

    Report

    Report Number
    9615050-2008-00098
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 28, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K770743
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. ONE SEALED DEVICE WAS EVALUATED. THE DEVICE PASSED TESTING. NO TUBING SEPARATION OR LEAKAGE WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION; SUBSEQUENTLY, A LEAK OF A CHEMOTHERAPEUTIC AGENT WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF ERBITUX. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED SOLUTION WAS LEAKING. IT WAS REPORTED THAT AS THE NURSE WAS CHECKING THE TUBING SET, THE TUBING SEPARATED FROM THE Y-SITE. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE SOLUTION CONTAINER AND THE TUBING SET WERE 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 SOLUSET VENTED 100 X 60 80 FPA FPA HOSPIRA DE COSTA RICA LTD. NA 490475G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK