BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD FILTER SOLUSET

    MDR report key: 1000846 · Received February 18, 2008

    Report

    Report Number
    9615050-2008-00042
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 21, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPB
    PMA / PMN Number
    K920736
    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 AIR IN THE TUBING DISTAL TO THE SOLUSET. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED THAT APPROXIMATELY 14 INCHES OF AIR WAS NOTED IN THE TUBING DISTAL TO THE SOLUSET. NO AIR WAS DELIVERED TO THE PATIENT. THE CUSTOMER CONTACT STATED THE TUBING SET WAS EITHER REPRIMED OR 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 FILTER SOLUSET 80-FPB FPB HOSPIRA DE COSTA RICA LTD. NA 530675H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK