BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2840313 · Received November 15, 2012

    Report

    Report Number
    1314492-2012-00421
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    July 16, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K043121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE NOT PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. A FLOW RATE TEST WAS ALSO PERFORMED WITH THE DEVICE IN QUESTION, PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE AND FOUND TO DELIVER WITHIN SPEC. ADD'L FLOW RATE TESTS WERE PERFORMED IN WHICH AN INACCURACY OF +8% WAS OBSERVED, HOWEVER, THIS IS NOT RELATED TO THE REPORTED UNDER INFUSION. REVIEW OF THE DEVICE HISTORY LOG SHOWS THAT ON THE REPORTED DATE OF THE EVENT, SEVEN FLOW CONFIRMATION PROMPTS WERE CONFIRMED AND MULTIPLE RATE CHANGES WERE PROGRAMMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS PROGRAMMED TO DELIVER DOPAMINE TO A PT (PROGRAMMED AMOUNT AND DELIVERY RATE UNK). IT WAS OBSERVED THAT THE PT'S BLOOD PRESSURE DID NOT INCREASE. THE CUSTOMER STATED THAT WHEN THE PUMP ALARMED FOR INFUSION COMPLETE, THE IV CONTAINER WAS STILL FULL. IT WAS ALSO REPORTED THAT WHEN THE PUMP WAS REPLACED, THE PT'S BLOOD PRESSURE INCREASED AS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR