BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 1579980 · Received January 14, 2010

    Report

    Report Number
    2921482-2010-00022
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 16, 2009
    Report Date
    December 17, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CUSTOMER CONTACT STATED THAT DURING A MEETING WITH THE NURSING STAFF AFTER THE REPORTED EVENT, THE IMPORTANCE OF CLAMPING THE TUBING PRIOR TO REMOVING THE TUBING SET FROM THE SYMBIC PUMP WAS EMPHASIZED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER FENTANYL 2500 MCG/250ML AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE INTUBATED PATIENT WAS ON VENTILATOR ASSIST SUPPORT; HOWEVER, THE PATIENT WAS ABLE TO TAKE SOME BREATHS ON HER OWN. IN 2009 AT APPROXIMATELY 2215, THE CUSTOMER CONTACT REPORTED THE FENTANYL THERAPY WAS ORDERED TO BE DISCONTINUED PRIOR TO REMOVING THE PATIENT FROM THE VENTILATOR. AT THIS TIME, THE NURSE REMOVED THE TUBING SET FROM THE DEVICE WITHOUT CLOSING THE CLAMP ON THE TUBING SET. IT WAS REPORTED AFTER THAT THE TUBING SET WAS REMOVED FROM THE DEVICE, PATIENT RECEIVED A BOLUS OF APPROXIMATELY 50-70ML BOLUS OF FENTANYL. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THE PATIENT WAS APNEIC. THE CUSTOMER CONTACT REPORTED THE PATIENT WAS TREATED WITH ONE HOUR OF FULL VENTILATOR SUPPORT AND RETURNED TO THE STATUS PRIOR TO EVENT. NO FURTHER MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R FENTANYL, MANUFACTURER UNK