BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2904416 · Received November 30, 2012

    Report

    Report Number
    1314492-2012-00467
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 2, 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 SPECIFICATION. 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. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, A PUMP WOULD NOT DELIVER FLUID. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    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