BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR .2 FLTR PP Y-SITE 96IN

    MDR report key: 2092984 · Received April 14, 2011

    Report

    Report Number
    9615050-2011-00256
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 2011
    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
    IL, 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 A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER 1L OF 1/2 NORMAL SALINE AND AN UNSPECIFIED CONCENTRATION OF SODIUM BICARBONATE AT A RATE OF 200ML/HR VIA A GEMSTAR PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING SEPARATED FROM THE FILTER OUTLET. 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 .2 FLTR PP Y-SITE 96IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA 952445H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR GEMSTAR PUMP: LIST #UNK, SN UNK