BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3843490 · Received March 14, 2014

    Report

    Report Number
    9615050-2014-01983
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT COMPLETE. 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 THE DEVICE ALARMED WITH A 9421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE. ON AN UNSPECIFIED TIME, AN UNSPECIFIED CHANNEL OF THE DEVICE WAS PROGRAMMED TO DELIVER NORMAL SALINE 0.9%, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE DEVICE ALARMED FOR AN UNSPECIFIED ALARM CODE AND BECAME INOPERABLE. THE DEVICE WAS REMOVED FROM CLINICAL USE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WAS NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING A REVIEW OF THE DEVICE HISTORY AT THE USER FACILITY, A S421 MALFUNCTION ALARM CODE WAS NOTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154140 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1