BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PED FLTR W/CLV

    MDR report key: 2180723 · Received May 5, 2011

    Report

    Report Number
    9613251-2011-00074
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 1, 2011
    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

    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 AIR IN THE TUBING DISTAL TO THE FILTER. THE OPTION-LOK MALE ADAPTERS OF THE EXTENSION SETS WERE CONNECTED TO UNSPECIFIED PRIMARY TUBING SETS AND WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT RATES BETWEEN 0.5ML/HR AND 10ML/HR, VIA UNSPECIFIED PUMPS. IT WAS REPORTED THAT AFTER UNSPECIFIED LENGTHS OF TIME, "AIR BUBBLES" WERE NOTED IN THE TUBING SETS. IT WAS REPORTED THAT THE AIR BUBBLES ACCUMULATED IN THE CLAVE Y-SITES THAT WERE DISTAL TO THE AIR ELIMINATING FILTER OF THE EXTENSION SETS. THE AIR WAS REMOVED FROM THE EXTENSION SETS AND THE THERAPIES RESUMED. NO AIR WAS DELIVERED 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 PED FLTR W/CLV 80FPA FPA HOSPIRA, LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED PRIMARY TUBING SET, LIST#UNK, LOT#UNK