BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PN SEC MACRO OL

    MDR report key: 1052472 · Received May 22, 2008

    Report

    Report Number
    9613251-2008-00163
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 28, 2008
    Report Date
    May 2, 2008
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. THE SECONDARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. IT WAS REPORTED THAT AFTER THE SECONDARY TUBING SETS WERE ATTACHED THE PROXIMAL Y-SITE OF THE UNSPECIFIED PRIMARY TUBING SETS, THE SOLUTIONS IN THE SECONDARY TUBING SETS WOULD NOT FLOW. IT WAS REPORTED THAT EITHER THE NURSES DISCONNECTED AND RECONNECTED THE SECONDARY TUBING SETS TO THE PRIMARY TUBINGS OR THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONV PN SEC MACRO OL 80-FPA FPA HOSPIRA, LTD NA 560394W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK