BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2911155 · Received December 7, 2012

    Report

    Report Number
    1314492-2012-00492
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. A FLOW RATE TEST WAS PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE AND FOUND TO DELIVER WITHIN SPEC. ADD¿L FLOW RATE TESTS WERE PERFORMED WITH THE UNIT PASSING. AN ADD¿L FLOW RATE TEST WAS PERFORMED USING THE BIOMEDICAL TESTING INFUSION PARAMETERS FOUND IN THE HISTORY LOG (FOR A PERIOD OF ONE HOUR) WITH THE UNIT PASSING. ADDITIONALLY, UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE UNIT ALSO PASSED ADD¿L UPSTREAM AND DOWNSTREAM OCCLUSION TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP FAILED FLOW RATE TESTING. THE CUSTOMER STATED THAT THE PUMP WAS PROGRAMMED TO DELIVER 50 ML AT A RATE OF 200ML/HR, HOWEVER, THE PUMP ONLY DELIVERED 28.5 ML.

    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