BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN

    MDR report key: 3161817 · Received June 3, 2013

    Report

    Report Number
    9615050-2013-01495
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 6, 2013
    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 DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING SET DISTAL TO THE AIR ELIMINATING FILTER. AT AN UNSPECIFIED TIME, THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TPN, AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF AIR WAS NOTED DISTAL TO THE AIR ELIMINATING FILTER OF THE TUBING SET. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THAT THE DELIVERY WAS STOPPED, THE TUBING SET WAS PURGED, AND THE DELIVERY WAS RESUMED. IT WAS REPORTED THAT AFTER THE DELIVERY WAS RESUMED, THE PUMP IMMEDIATELY ALARMED FOR DISTAL OCCLUSION. AT THIS TIME, THE PT'S MOTHER STOPPED THE DELIVERY. AT 0500, THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242520 MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA 231735H

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR GEMSTAR PUMP, LIST #13087, SN (B)(4)