BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 SINGLE C

    MDR report key: 3886275 · Received April 9, 2014

    Report

    Report Number
    9615050-2014-02601
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE ALARMED WITH A S321 MALFUNCTION ALARM DURING THE DELIVERY ACCURACY TEST. A REVIEW OF THE DEVICE HISTORY INDICATED S321 MALFUNCTION ALARM WITH A MALFUNCTION CODE: QEP COUNT HIGH. THE PROBABLE CAUSE OF THE S321 MALFUNCTION ALARM CODE WAS A BROKEN MOTOR ENCODER. 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 THE DEVICE ALARMED WITH A S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF A S321 MALFUNCTION ALARM CODE. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215994 SYMBIQ 3.13 SINGLE C 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK