BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 3113151 · Received May 8, 2013

    Report

    Report Number
    9615050-2013-01086
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 9, 2013
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE DEVICE HISTORY WAS DOWNLOADED AT THE CUSTOMER FACILITY. THE CUSTOMER DID NOT PROVIDE AN EVENT DATE; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL TO THE DEVICE WITH NO DEVICE ALARM. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED FOR BASIC DELIVERY OF 0.9% SODIUM CHLORIDE, AT A RATE OF 15ML/HR, AN AIR IN LINE SETTING OF 500MCL, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WHERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED AIR IN THE TUBING SET, APPROX 12 INCHES IN LENGTH DISTAL TO THE DEVICE WITH NO DEVICE ALARM. AT THAT TIME, THE NURSE STOPPED THE DELIVERY AND DISCONNECTED THE TUBING SET FROM THE PT. THE NURSE REPORTED NO AIR WAS DELIVERED TO THE PT. THE DEVICE WAS REMOVED FROM CLINICAL USE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING IF THERAPY WAS RESUMED USING A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202328 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK