BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SCHANNEL 3.01

    MDR report key: 4110415 · Received September 16, 2014

    Report

    Report Number
    9615050-2014-05255
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    FA212-03 FA211-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INITIALLY PASSED TESTING. A WHITESCREEN ERROR WAS NOT DISPLAYED DURING THE TESTING PROCEDURES. ALTHOUGH THE DEVICE PASSED TESTING, A REVIEW OF THE HISTORY INDICATED A WHITESCREEN ERROR. THE WHITESCREEN ERROR OCCURRED WHEN THE USER TITRATED ONLY THE RATE WHEN THE DEVICE WAS DELIVERING IN THE KVO MODE. FURTHER TESTING FOUND THE DEVICE DID NOT PASS THE SDRAM TEST. THIS WAS DUE TO THE SOM 2 HARDWARE MODULE. AS INDICATED IN SECTION H7, 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 THAT THE DEVICE ALARMED WITH A WHITESCREEN ERROR. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FROM AN UNK FLOOR WITH NO NOTE ATTACHED. 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. DURING TESTING AT THE USER FACILITY AFTER THE DEVICE WAS POWERED ON, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573970 SYMBIQ SCHANNEL 3.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK