BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 5232310 · Received November 18, 2015

    Report

    Report Number
    1314492-2015-11048
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 27, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE FALSE AIR IN LINE ALARMS WHICH WERE NOT REPRODUCED. THE ALARMS WERE CONFIRMED DURING A REVIEW OF THE EVENT HISTORY LOG. IT WAS OBSERVED THAT THE UPSTREAM SENSOR HAD LOW FLUID NUMBERS. LOW ULTRASONIC READINGS HAVE BEEN KNOWN TO CONTRIBUTE TO FALSE AIR IN LINE ALARMS. THE FAILED UPSTREAM SENSOR WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP CONSTANTLY DISPLAYED THE AIR IN LINE MESSAGE. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762273 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1