BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 2CLV YSTE MICR

    MDR report key: 2181095 · Received July 7, 2011

    Report

    Report Number
    9613251-2011-00155
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 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 NO FLOW. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS VIA GRAVITY. THE OPTION-LOK MALE ADAPTERS OF THE TUBING SETS WERE CONNECTED TO UNSPECIFIED EXTENSION SETS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE REPORTEDLY AFTER THE TUBING SET HAD WARMED UP, NO FLOW OF SOLUTION IN THE DRIP CHAMBERS WERE NOTED. IT WAS REPORTED THAT THE TUBING OF THE TUBING SETS HAD KINKED WHERE THE TUBING SETS HAD BEEN TAPED TO THE PATIENTS. IT WAS REPORTED THAT THE NURSES UNTAPED AND REPOSITIONED THE TUBING SETS AND THE THERAPIES WERE RESUMED. THE CUSTOMER CONTACT INDICATED THAT THE NURSES HAVE BEEN INSERVICED ON TAPING OF THE TUBING SET TO THE PATIENTS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF THERAPY CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP 2CLV YSTE MICR 80FPA FPA HOSPIRA LTD. NA 940984W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED EXTENSION SETS, LIST# UNK, LOT# UNK