BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 1940743 · Received December 22, 2010

    Report

    Report Number
    2921482-2010-01022
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 3, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND CHANNEL B OF THE DEVICE ALARMED S421 (MOTOR ERROR, PMC, RIGHT). THIS WAS FOUND DUE TO THE POWER MOTOR CONTROLLER ON CHANNEL B. THIS PRODUCT HAS BEEN IDENTIFIED AS PART OF A CUSTOMER NOTIFICATION DATED, (B)(4) 2010. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, CHANNEL B WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF EPINEPHRINE, AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE DEVICE "FAILED WITH NO WARNING". AT THAT TIME, THE NURSE REPORTED AN UNSPECIFIED DECREASE IN THE PT'S BLOOD PRESSURE. THE PHYSICIAN WAS NOTIFIED. THE PHYSICIAN TREATED THE PT WITH AN UNSPECIFIED CONCENTRATION OF EPINEPHRINE IV PUSH. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DELIVERY WAS RESUMED ON CHANNEL A OF THE SAME DEVICE. THOUGH REQUESTED, NO ADD'L INFO 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 UNK Life Threatening| R EPINEPHRINE, MFR UNK.