BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2982390 · Received January 25, 2013

    Report

    Report Number
    1314492-2013-00042
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION. THE PUMP WAS NOT OBSERVED TO POWER ON AND OFF WITHOUT USER INPUT, HOWEVER A "CHECK BATTERY" ALARM WAS CONFIRMED IN THE DEVICE HISTORY LOG. THE CAUSE WAS DETERMINED TO BE CONTACT BETWEEN THE SCANNER BRACKET SCREW AND THE 2 TRACES OF THE BACKFLEX CAUSING SHORTING. SHORTING OF THE BACKFLEX MAY CAUSE THE DEVICE TO POWER ON WITHOUT USER INPUT, ENTER SLEEP MODE AND SHUTDOWN WITHOUT USER INPUT, WHILE OPERATING ON POWER SUPPLIED FROM A BATTERY MODULE ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP POWERS ON AND OFF WITHOUT USER INPUT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36510 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1