BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ TWO-CHANNEL INFUSION SYSTEM

    MDR report key: 1170794 · Received September 15, 2008

    Report

    Report Number
    2921482-2008-00290
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    HOSPIRA, INC
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY DURING AN ALARM CONDITION. AT 0419, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DOPAMINE AT A RATE OF 20MCG/KG/MIN AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. BETWEEN 0530 AND 0944, THE DEVICE SOUNDED AUDIBLE ALARM TONES. DURING THE ALARM CONDITIONS, THE NURSE REPORTED A "SIGNIFICANT DELAY IN CARE TO A CRITICALLY ILL PATIENT"; HOWEVER, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR