BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4781087 · Received May 15, 2015

    Report

    Report Number
    1314492-2015-06012
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 21, 2015
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND WITHIN SPECIFICATION WITH RESPECT TO THE REPORTED SYMPTOM, WHICH WAS NOT REPRODUCED. EVALUATION FOUND THE DEVICE ABLE TO CHARGE A KNOWN GOOD BATTERY AND RUN AN INFUSION WITHOUT POWERING OFF. THE MESSAGES WERE CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY LOG HOWEVER NO DEVICE MALFUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP OFF WITHOUT USER INPUT. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318027 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1