BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD CONV SOLUSET

    MDR report key: 1052976 · Received May 27, 2008

    Report

    Report Number
    9615050-2008-00150
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K912103
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE FLOAT VALVE IN THE SOLUSET DID NOT CLOSE WHEN THE SOLUSET EMPTIED; SUBSEQUENTLY, AIR WAS NOTED IN THE TUBING. THE SOLUSET WAS BEING USED FOR DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE SOLUSET EMPTIED AND THE SHUT OFF VALVE DID NOT CLOSE; SUBSEQUENTLY, AIR WAS NOTED DISTAL TO THE SOLUSET. IT WAS REPORTED THAT NO AIR WAS DELIVERED TO THE PATIENT. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD CONV SOLUSET 80-FPK FPK HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK