BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ ONE-CHANNEL INFUSION SYSTEM

    MDR report key: 1211248 · Received October 16, 2008

    Report

    Report Number
    2921482-2008-00329
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED IN THE PIGGYBACK MODE TO DELIVER MAGNESIUM 2MG/50ML, AT A RATE OF 50ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED UNRESTRICTED FLOW. THE DELIVERY WAS STOPPED, THE TUBING SET REPLACED, AND THERAPY RESUMED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE AGAIN NOTED UNRESTRICTED FLOW. THE DEVICE AND TUBING SET WERE REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE AND TUBING SET. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ ONE-CHANNEL INFUSION SYSTEM 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK