BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3905878 · Received May 29, 2014

    Report

    Report Number
    9615050-2014-03714
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 30, 2014
    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
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE ALARMED WITH A S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE. THE PROBABLE CAUSE WAS A LOOSE MOTOR DUE TO THE UNDER APPLICATION OF THE ADHESIVE SEAL OR THE ADHESIVE SEAL BEING APPLIED OVER GREASE. DURING A REVIEW OF THE DEVICE HISTORY A S321 ALARM "PUMP QEP COUNT LOW" WAS NOTED. THE PROBABLE CAUSE MAY BE DUE TO A BROKEN ENCODER ON THE MOTOR. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE ALARMED WITH A S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED "ALARMS MALFUNCTION S421". NO INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317170 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK