BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN

    MDR report key: 3161835 · Received June 3, 2013

    Report

    Report Number
    9615050-2013-01496
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 29, 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 RECEIVED. 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 2300, IT WAS REPORTED THAT THE TUBING SET WAS BEING USED TO DELIVER TPN WITH A VOLUME TO BE INFUSED (VTBI) OF 2160ML, FOR A DURATION OF 17HR, WITH A 30MIN TAPER UP AND A 30MIN TAPER DOWN, VIA A GEMSTAR PUMP. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED VOLUME OF AIR WAS NOTED DISTAL TO THE AIR ELIMINATING FILTER. IT WAS REPORTED THAT THE DELIVERY WAS STOPPED AND THE TUBING SET WAS PURGED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE THERAPY WAS RESUMED. AT THIS TIME, THE PUMP ALARMED FOR DISTAL OCCLUSION. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. NO AIR WAS DELIVERED TO THE PT. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243612 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)