BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 1910424 · Received November 18, 2010

    Report

    Report Number
    2921482-2010-00917
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 21, 2010
    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
    AL, 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF INSULIN AT AN UNSPECIFIED RATE REPORTED TO BE LESS THAN 1ML/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE REPORTED THE PT'S BLOOD GLUCOSE WAS "1400". AT THAT TIME, THE PHYSICIAN NOTED THE TUBING SET WAS CLAMPED DISTAL TO THE DEVICE WITH NO DEVICE ALARM. THE CUSTOMER CONTACT COULD NOT SPECIFY HOW LONG THE TUBING SET HAD BEEN CLAMPED. THE PT WAS TREATED WITH AN UNSPECIFIED BOLUS DOSE OF INSULIN AND THERAPY WAS RESUMED USING THE SAME DEVICE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE BLOOD GLUCOSE WAS REPEATED AND DRAWN FROM THE UVC (UMBILICAL VEIN CATHETER); THE RESULTS WERE UNSPECIFIED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R INSULIN, MFR UNK