BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD FILTER SOLUSET

    MDR report key: 1011819 · Received March 11, 2008

    Report

    Report Number
    9615050-2008-00066
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 19, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICES WERE DISCARDED. A REP DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF AIR IN THE TUBINGS DISTAL TO THE SOLUSETS. THE TUBING SETS WERE BEING USED TO DELIVER 0.9% NORMAL SALINE. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE SOLUSETS EMPTIED AND AIR WAS REPORTED DISTAL TO THE SOLUSETS. NO AIR WAS DELIVERED TO THE PTS. THE CUSTOMER CONTACT STATED THE TUBING SETS WERE EITHER REPRIMED OR REPLACED AND THE THERAPIES WERE 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 LIFESHIELD FILTER SOLUSET 80-FPB FPB HOSPIRA DE COSTA RICA LTD. NA 440185H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK