BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2896703 · Received November 21, 2012

    Report

    Report Number
    1314492-2012-00454
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    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 THE DEVICE WAS FOUND TO DELIVER WITHIN SPEC. AN ADDITIONAL FLOW RATE TEST WAS PERFORMED USING THE EVENT INFUSION PARAMETERS FOUND IN THE HISTORY LOG (FOR A PERIOD OF ONE HOUR) WITH THE UNIT PASSING. UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE ALSO PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE PUMP WAS ALSO TESTED AND WAS ABLE TO CORRECTLY CHARGE A BATTERY. THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WOULD NOT DELIVER FLUID DURING PREVENTIVE MAINTENANCE TESTING. IT WAS ALSO REPORTED THAT THE PUMP WILL NOT CHARGE THE BATTERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1