BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET VENTED 100 X 60

    MDR report key: 1011820 · Received March 11, 2008

    Report

    Report Number
    9615050-2008-00067
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 14, 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
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REP DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE DOMESTIC LIST NUMBER THAT IS COMPARABLE TO THE INTL LIST NUMBER. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE FLOAT VALVE OF THE SOLUSET WAS STUCK TO THE WALL OF THE SOLUSET. THE SOLUSET WAS TO BE USED TO DELIVER AN UNSPECIFIED SOLUTION AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT AS THE NURSE WAS CONNECTING THE SOLUSET TO THE PT, SHE NOTED THAT THE SOLUSET FLOAT VALVE WAS STUCK TO THE WALL OF THE SOLUSET. 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 491875G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK