BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN

    MDR report key: 1880990 · Received October 5, 2010

    Report

    Report Number
    9615050-2010-00185
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 10, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL TO THE FILTER. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TPN VIA A GEMSTAR PUMP. AT AN UNSPECIFIED TIME, THE HOMECARE PATIENT¿S SON PRIMED THE TUBING SET USING THE GEMSTAR PUMP AND CONNECTED THE TUBING SET TO THE PATIENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT AIR WAS NOTED IN THE TUBING DISTAL TO THE FILTER. THE VOLUME OF AIR WAS REPORTED TO BE 10MM IN LENGTH. NO AIR WAS DELIVERED TO THE PATIENT. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRBR GEMSTR 1.2 FLTR PP Y-SITE 96IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA 891105H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR LIST #UNK, SN UNK| GEMSTAR PUMP