BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD SECONDARY SET WITH CONV PIN

    MDR report key: 1133047 · Received August 22, 2008

    Report

    Report Number
    9613251-2008-00305
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 31, 2008
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K933326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF BACKFLOW OF SOLUTIONS FROM THE SECONDARY TUBING SETS INTO THE PRIMARY TUBING SET. THE PRIMARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. THE SECONDARY TUBING SETS WERE BEING USED FOR PIGGYBACK DELIVERIES OF UNSPECIFIED ANTIBIOTICS AND WERE CONNECTED TO THE PRIMARY TUBING SETS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, IT WAS REPORTED THAT THE ANTIBIOTIC SOLUTIONS BACKFLOWED INTO THE PRIMARY TUBING SETS. 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 SECONDARY SET WITH CONV PIN 80-FPA FPA HOSPIRA, LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED PRIMARY TUBING SET| MANUFACTURED BY BAXTER INTERNATIONAL