BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4843987 · Received June 5, 2015

    Report

    Report Number
    1314492-2015-06555
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE AND FOUND THAT THE DOWNSTREAM SENSOR WAS FAILING. IT WAS DETERMINED THAT THIS FAILING PART CAUSED THE FALSE DOWNSTREAM OCCLUSION ALARMS AND HAS BEEN REPLACED.

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY LOG IT WAS DETERMINED THAT A REPEATING PATTERN OF DOWNSTREAM OCCLUSION ALARMS SUGGESTS THAT THE DEVICE WAS FALSELY ALARMING FOR DOWNSTREAM OCCLUSIONS. THE OCCURRENCES SUGGEST A DEVICE MALFUNCTION. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366168 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1