BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935150 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05622
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION COULD NOT CONFIRM NO REPRODUCE THE REPORTED UNDETECTED AIR-IN-LINE. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION AND PASSED ALL AIR-IN-LINE DETECTION TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WOULD NOT DETECT AN AIR PRESENT IN THE TUBING. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69729 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1