BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR .2 FLTR PP Y-SITE 96IN

    MDR report key: 1942060 · Received November 9, 2010

    Report

    Report Number
    9615050-2010-00227
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 14, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE INDICATED. 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. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF AIR DISTAL TO THE FILTERS. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS VIA GEMSTAR PUMPS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE PUMPS ALARMED FOR AIR IN LINE; HOWEVER, IT WAS REPORTED THAT AIR "ABOUT 1/4 INCH IN LENGTH" WAS NOTED IN THE TUBING'S DISTAL TO THE FILTERS. NO AIR WAS DELIVERED TO THE PTS. THE AIR WAS REMOVED FROM THE TUBING SETS AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRBR GEMSTR .2 FLTR PP Y-SITE 96IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK