BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD CONV SOLUSET

    MDR report key: 1023681 · Received April 1, 2008

    Report

    Report Number
    9615050-2008-00083
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 12, 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
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. THE SOLUSETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS AND MEDICATIONS. IT WAS REPORTED THAT AFTER THE SOLUSETS WERE PRIMED AND CONNECTED TO THE PTS THE SOLUTIONS WOULD NOT FLOW. 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 LIFESHIELD CONV SOLUSET 80-FPK FPK HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK