BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4875888 · Received June 26, 2015

    Report

    Report Number
    1314492-2015-07149
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 4, 2015
    Manufacturer
    BAXTER HLTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. THE INVESTIGATION HAS NOT BEEN COMPLETED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND IN SPECIFICATION IN RELATION TO THE REPORTED FAILED FLOW RATE TEST, AND COULD NOT BE REPRODUCED. UPON REVIEW OF THIS EVALUATION, IT WAS CONCLUDED THAT THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED AND THIS EVENT IS DETERMINED TO NOT BE A REPORTABLE EVENT. MANUFACTURER REPORT NUMBER 131442-2015-07149 CAN BE REMOVED FROM THE FDA DATABASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP FAILED THE FLOW RATE TEST (FIVE TIMES) DURING PREVENTIVE MAINTENANCE TESTING. IT WAS ALSO REPORTED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414402 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HLTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1