BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3222011 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01035
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER WAS SEEING AN INCREASE IN THE AMOUNT OF SPECTRUM PUMP'S THAT WERE ALARMING FALSELY FOR UPSTREAM OCCLUSION. THE CUSTOMER REPORTED THAT HE HAS HAD 14 OR 15 DEVICES THIS YEAR EXPERIENCING THIS ISSUE. THE CUSTOMER TESTS THE DEVICES WITH WATER AND STATED THAT THIS ALARM SHOULD NOT OCCUR DUE TO THE LACK OF AN OCCLUSION IN THE IV LINE. HE STATED THAT HE CANNOT IDENTIFY A SPECIFIC DEVICE AT THIS TIME EXPERIENCING THIS ISSUE, BUT JUST WANTED TO REPORT THAT IT IS A GROWING PROBLEM. THERE WAS NO PT INJURY RELATED TO THESE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307609 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1