BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN

    MDR report key: 4253325 · Received November 12, 2014

    Report

    Report Number
    9615050-2014-06026
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    July 1, 2014
    Report Date
    October 20, 2014
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING SET. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TPN (TOTAL PARENTERAL NUTRITION) WITH LIPIDS, AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. NO SPECIFIC PUMP PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT WITHIN ONE HOUR AFTER THE DELIVERY WAS STARTED, THE PATIENT REPORTED THAT AIR WAS BELOW THE FILTER. IT WAS REPORTED THAT IT WAS DISCONNECTED AND PUSHED PRIME TO SEE IF THERE WAS JUST AIR IN THE FILTER AND AIR KEPT COMING OUT. IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONALS WERE ABLE TO SUCCESSFULLY RESUME THERAPY. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PATIENT AFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729619 MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA 372015H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED GEMSTAR PUMP, LIST #UNK, SN: UNK