BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 SINGLE C

    MDR report key: 2904138 · Received January 3, 2013

    Report

    Report Number
    9615050-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 2, 2012
    Report Date
    December 6, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RECEIVED, A F/U REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A CHANGE IN THE PROGRAMMED SETTINGS, RESULTING IN THE PT RECEIVING LESS MEDICATION THAT INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER 5% DEXTROSE/NORMAL SALINE WITH 20 MEQ POTASSIUM CHLORIDE, AT A RATE OF 125 ML/HR. NO FURTHER PROGRAMMING PARAMETERS WHERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE ENTERED THE PT'S ROOM TO CLEAR THE VOLUME TOTALS. AT THAT TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE NOTED THE DEVICE WAS IN STANDBY MODE, AND THE PROGRAMMED SETTINGS HAD BEEN CLEARED. THE CUSTOMER CONTACT REPORTED THAT THE TUBING SET WAS REPLACED, AND THERAPY WAS RESUMED BY PROGRAMMING THE SAME DEVICE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED, INCLUDING IF THERE WAS A DELAY IN CRITICAL THERAPY, ADVERSE EVENT OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3486 SYMBIQ 3.13 SINGLE C 80FRN FRN HOSPIRA COSTA RICA LTD.

    Patients

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