BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ 3.13 DUAL CHA

    MDR report key: 4251340 · Received November 5, 2014

    Report

    Report Number
    9615050-2014-05917
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 14, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MECHANISM WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 AN S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE. THE DEVICE WAS INITIALLY RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "S421 MALFUNCTION ALARM." NO INFORMATION WAS PROVIDED; THEREFORE, NO SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED FOR S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710218 SYMBIQ 3.13 DUAL CHA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK