BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 2861587 · Received November 28, 2012

    Report

    Report Number
    9615050-2012-01426
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 21, 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
    NURSE

    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 VERSED. THE OTHER CHANNEL OF THE DEVICE WAS PROGRAMMED FOR DELIVERY OF AN UNSPECIFIED CONCENTRATION OF FENTANYL AND THE DELIVERY WAS STARTED. AFTER APPROX 8 HOURS, THE DEVICE ALARMED FOR PROXIMAL OCCLUSION. THE NURSE REPORTED NO PROXIMAL OCCLUSION WAS NOTED. AT THAT TIME, THE NURSE REMOVED AND RELOADED THE TUBING SET INTO THE DEVICE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE ALARMED FOR PROXIMAL OCCLUSION. 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, INCLUDING IF THERAPY WAS RESUMED USING THE SAME DEVICE OR A REPLACEMENT DEVICE.

    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 SYMBIQ TUBING SET, LIST #16068, LOT #UNK