BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3043455 · Received March 12, 2013

    Report

    Report Number
    1314492-2013-00225
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL AND THEREFORE AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP STARTED AN INFUSION WITHOUT USER INPUT. THE PUMP WAS PROGRAMMED AND PLACED INTO STANDBY MODE (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER STATED THAT THE PUMP ALARMED FOR A LOT BATTERY, AND THE CLINICIAN PLUGGED THE POWER ADAPTOR INTO THE OUTLET. THE DEVICE THEN EXITED STANDBY MODE AND STARTED THE INFUSION WITHOUT USER INPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104450 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1