BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL W/FILTERTEK VALVE

    MDR report key: 2651772 · Received July 9, 2012

    Report

    Report Number
    9615050-2012-00753
    Event Type
    Malfunction
    Date Received
    July 9, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND A 510K OF K103344. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF IV IMMUNE GLOBULIN 10% 32.5 GM, THAT WAS TITRATED TO A RANGE OF 200 ML/HR. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED BACKFLOW OF SOLUTION INTO THE PRIMARY SOLUTION CONTAINER. IT WAS REPORTED THAT THE TUBING OF THE PRIMARY TUBING SET WAS CLAMPED WITH A HEMOSTAT AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIM SYM SET 2 CL W/FILTERTEK VALVE UNK FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT #UNK| UNSPECIFIED SECONDARY TUBING SET: LIST #UNK,