BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF PP PRIM SYM SET PGB W/BCKCK V 2 CL

    MDR report key: 2181292 · Received July 8, 2011

    Report

    Report Number
    9615050-2011-00499
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 25, 2011
    Report Date
    June 14, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 TUBING SET. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION AT AN UNSPECIFIED RATE VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED AT AN UNSPECIFIED LOCATION ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF TAZOCIN AND FLAGYL. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, BACKFLOW OF SOLUTION FROM THE SECONDARY TUBING SET INTO THE PRIMARY TUBING SET WAS NOTED. IT WAS REPORTED THAT THE SECONDARY TUBING SET WAS CLAMPED AND THE PRIMARY TUBING SET REMAINED IN CLINICAL USE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING IF SECONDARY TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF PP PRIM SYM SET PGB W/BCKCK V 2 CL 80FPA FPA HOSPIRA COSTA RICA LTD. NA 911685H

    Patients

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