BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LTX FR CONV SOLST

    MDR report key: 1883133 · Received October 19, 2010

    Report

    Report Number
    9615050-2010-00203
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 19, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED, THE DEVICES WERE DISCARDED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. NO. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE FLOAT VALVE IN THE SOLUSET TUBING SETS DID NOT CLOSE WHEN THE SOLUSETS EMPTIED. THE SOLUSETS WERE BEING USED TO DELIVER 100ML OF UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE SOLUSETS EMPTIED AND THE SHUT OFF VALVES DID NOT CLOSE. NO AIR WAS DELIVERED TO THE PTS. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LTX FR CONV SOLST 80FPK FPK HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1