BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2861588 · Received November 28, 2012

    Report

    Report Number
    9615050-2012-01428
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 30, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    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 WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 A DELAY IN CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED FOR DELIVERY OF AN UNSPECIFIED CONCENTRATION OF DOPAMINE. THE OTHER CHANNEL WAS PROGRAMMED FOR DELIVERY OF AN UNSPECIFIED CONCENTRATION OF HEPARIN, AT A RATE OF 2ML/HR AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE ALARMED FOR PROXIMAL OCCLUSION. AT THAT TIME, THE NURSE REMOVED THE TUBING SET FROM THE DEVICE AND RELOADED THE TUBING SET INTO THE DEVICE. THERAPY WAS RESUMED USING THE SAME TUBING SET AND DEVICE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE ALARMED FOR PROXIMAL OCCLUSION. AT THAT TIME, THE NURSE REPLACED THE TUBING SET AND THE THERAPY WAS RESUMED USING THE SAME DEVICE. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR SYMBIQ TUBING SET, LIST #16068, LOT #UNK