BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DCHANNEL 3.01

    MDR report key: 3822772 · Received February 7, 2014

    Report

    Report Number
    9615050-2014-00977
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 8, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    FA212-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING. DURING TESTING A REVIEW OF THE DEVICE HISTORY MULTIPLE PROXIMAL OCCLUSION ALARMS WERE NOTED. THE POSSIBLE CAUSE OF THE CUSTOMER'S REPORTED EVENT ARE CASSETTE DIAPHRAGM STRESS RELAXATION, PROXIMAL PIN FRICTION, DROP IN PRESSURE READING AT DOSE START, BACK-CHECK VALVE (NP AND FILTERTEK) EFFECTS ON PRESSURE, AND SENSOR NOISE (ELECTRONIC AND MECHANICAL/FLUIDIC). ALTHOUGH THE DEVICE PASSED TESTING, THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARM FOR A PROXIMAL OCCLUSION AND THE ALARM COULD NOT BE CLEARED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80853 SYMBIQ DCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA