BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2961072 · Received January 16, 2013

    Report

    Report Number
    1314492-2013-00031
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Report Date
    December 20, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION. UPSTREAM OCCLUSION SENSOR TESTS AND DOWNSTREAM OCCLUSION SENSOR TESTS WERE PERFORMED PER THE BAXTER PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE UNIT ALSO PASSED ADD'L INSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS. A REVIEW OF THE HISTORY LOG DURING THE LAST INFUSION SHOWS THE DEVICE WAS PROGRAMMED TO DELIVER 50ML AT A RATE OF 4.3 ML/HR. DURING THE INFUSION, THE DELIVERY RATE WAS CHANGED ON MULTIPLE OCCASIONS AND THE DEVICE ALARMED FOR AN UPSTREAM OCCLUSION FOURTEEN TIMES. FOUR HOURS AFTER THE START OF THE INFUSION, A "BAG NEAR EMPTY ALERT" WAS ACKNOWLEDGED. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP "FAILED TO ALARM FOR AN UPSTREAM OCCLUSION CONDITION AND DISPLAYED A DELIVERED VOLUME WHEN NO SOLUTION HAD BEEN DELIVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24996 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1