BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRBR GEMSTR .2 FLTR PP Y-SITE 96IN

    MDR report key: 3821143 · Received April 16, 2014

    Report

    Report Number
    9615050-2014-02753
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 16, 2014
    Report Date
    March 17, 2014
    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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS REC'D AND EVALUATED. TESTING FOUND THAT THE PROXIMAL TUBING TO THE FILTER WAS SEPARATED FROM THE FILTER. THIS WAS DUE TO INSUFFICIENT SOLVENT APPLICATION. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED ONE POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 311475H. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS 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 A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED ANTIBIOTIC, AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE FILTER OF THE TUBING SET. THE CUSTOMER CONTACT REPORTED THAT THE TUBING POPPED OUT OF THE FILTER. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED. THE CUSTOMER CONTACT REPORTED A MISSED DOSE; HOWEVER, THERE WERE NO ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL FOR THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232528 MICRBR GEMSTR .2 FLTR PP Y-SITE 96IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK