BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD SYMBIQ SET WITH 2 CLAVES

    MDR report key: 1193457 · Received October 7, 2008

    Report

    Report Number
    9615050-2008-00292
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY TUBING SET INTO THE PRIMARY TUBING SET. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER NORMAL SALINE VIA A SYMBIQ PUMP. THE SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF DOXORUBICIN IN A 500ML SOLUTION CONTAINER. THE PRIMARY SOLUTION CONTAINER WAS LOWERED WITH "2 HANGERS" BELOW THE SECONDARY SOLUTION CONTAINER; HOWEVER, THE NURSE NOTED THE SECONDARY SOLUTION WAS FLOWING INTO THE PRIMARY TUBING SET. IT WAS REPORTED THE PRIMARY TUBING SET WAS CLAMPED BELOW THE BACK CHECK VALVE AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD SYMBIQ SET WITH 2 CLAVES 80-FRN FRN HOSPIRA DE COSTA RICA LTD. NA 631505H

    Patients

    Seq Age Sex Outcome Treatment
    1 LIST # 11953| LOT # UNK| LIFESHIELD SECONDARY TUBING SET