BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD SYMBIQ SET WITH 2 CLAVES

    MDR report key: 1193459 · Received October 7, 2008

    Report

    Report Number
    9615050-2008-00291
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 15, 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
    PHARMACIST

    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 SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION VIA A SYMBIQ PUMP. THE SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF DOXORUBICIN AT A RATE OF 10ML/HR. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THE SECONDARY SOLUTION WAS FLOWING INTO THE PRIMARY SOLUTION CONTAINER. IT WAS REPORTED THE NURSE CLAMPED THE PRIMARY TUBING SET AND THE DOXORUBICIN DELIVERY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 LIFESHIELD SECONDARY SET: LOT #UNK