BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 4212891 · Received August 4, 2014

    Report

    Report Number
    9615050-2014-04675
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 11, 2015
    Report Date
    July 15, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    Z0070-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE AUDIBLY ALARMED ON STARTUP WITH MALFUNCTION ALARM S321 (MOTOR ERROR) AND "BATTERY RECONDITION". FURTHER TESTING, FOUND THE DEVICE TOUCHSCREEN WAS RESPONSIVE WHEN PRESSED, BUT KEY ALIGNMENT WAS OFF. THE TOUCHSCREEN WAS RECALIBRATED AND THE KEY ALIGNMENT ISSUE WAS RESOLVED. THE PROBABLE CAUSE OF THE CUSTOMER REPORTED TOUCHSCREEN CALIBRATION BEING OFF WAS DUE TO CONTAMINATION CAUSED BY FLUID INGRESS FOUND ON THE BOTTOM OF THE TOUCHSCREEN. THE PROBABLE CAUSE OF THE MALFUNCTION ALARM S321 OBSERVED DURING TESTING WAS A BROKEN RTV SEAL ON THE MOTOR. THIS WAS DUE TO EITHER THE RTV BEING UNDER-APPLIED TO THE SPECIFICATION, OR EXCESS GREASE FROM THE O-RING INSTALLATION WAS NOT REMOVED AND THE RTV IS APPLIED OVER THE GREASE. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 TOUCHSCREEN CALIBRATION WAS TOO FAR OFF. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR AN UNSPECIFIED REASON. 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
    455518 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK