BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN

    MDR report key: 3161833 · Received June 3, 2013

    Report

    Report Number
    9615050-2013-01494
    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. ON (B)(6) 2013 AT 2230, IT WAS REPORTED THAT THE TUBING SET WAS BEING USED TO DELIVER TPN WITH A VOLUME TO BE INFUSED (VTBI) OF 2160 ML, FOR A DURATION OF 17 HRS, WITH A 30 MIN TAPER UP AND A 30 MIN TAPER DOWN, VIA A GEMSTAR PUMP. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2013 AT 0000, THE PT'S MOTHER REPORTED THAT THE PUMP ALARMED FOR DISTAL OCCLUSION. AT 0130, THERAPY WAS RESUMED WITH A REPLACEMENT PUMP; HOWEVER, THE TUBING SET REMAINED IN CLINICAL USE. AT UNSPECIFIED TIMES, IT REPORTED THAT THE PUMP AGAIN ALARMED FOR DISTAL OCCLUSION. NO SPECIFIC DETAILS WERE PROVIDED. AT AN UNSPECIFIED TIME, THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. A VISUAL EXAMINATION OF THE TUBING SET FOUND AN UNSPECIFIED VOLUME OF AIR DISTAL TO THE AIR ELIMINATING FILTER OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT NO AIR WAS DELIVERED TO THE PT. 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
    243602 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)| GEMSTAR PUMP, LIST #13087, SN (B)(4)