BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 150 X 60 BURETTE SET, LATEX FREE

    MDR report key: 1230824 · Received November 6, 2008

    Report

    Report Number
    9615050-2008-00324
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 10, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. THE CATALOG NUMBER PROVIDED IS THE DOMESTIC LIST NUMBER THAT IS COMPARABLE TO THE INTL LIST NUMBER IN THE "OTHER" FIELD.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE FLOAT VALVE IN THE SOLUSET DID NOT CLOSE WHEN THE SOLUSET EMPTIED. THE SOLUSET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE FLOAT VALVE IN THE SOLUSET DID NOT CLOSE WHEN THE SOLUSET EMPTIED. IT WAS REPORTED THAT NO AIR WAS DELIVERED TO THE PT. THE TUBING SET WAS REPLACED AND 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 SOLUSET 150 X 60 BURETTE SET, LATEX FREE 80-FPK FPK HOSPIRA DE COSTA RICA LTD. NA 571335G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK