BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4843966 · Received June 5, 2015

    Report

    Report Number
    1314492-2015-06601
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 13, 2015
    Manufacturer
    BAXTER HLTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE "AIR IN LINE SENSOR" ISSUE, WHICH WAS NOT REPRODUCED. AIR IN LINE ALARMS WERE CONFIRMED DURING A REVIEW OF THE EVENT HISTORY LOG. DURING THE EVAL, CRACKS WERE FOUND ON THE UPSTREAM SENSOR TAIL PIN. THE FAILED UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD AN ISSUE WITH THE "AIR IN LINE SENSOR." IT WAS ALSO REPORTED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366140 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HLTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1