BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3192528 · Received June 4, 2013

    Report

    Report Number
    1314492-2013-00703
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP WAS RECEIVED BY BAXTER AND THE REPORTED FALSE UPSTREAM OCCLUSION ALARM WAS CONFIRMED. EVAL FOUND THE UPSTREAM SENSOR SIGNAL TO BE OUT OF SPECIFICATION. THE UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WOULD ALARM FOR UPSTREAM OCCLUSION, WHEN NO OCCLUSION WAS PRESENT. THE CUSTOMER REPORTED THAT THE PUMP WAS RAN AT A RATE OF 250 ML/HR, AND AFTER 10 MINUTES THE PUMP WOULD ALARM FALSELY FOR UPSTREAM OCCLUSION. THIS ISSUE WAS DISCOVERED DURING TESTING, AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247819 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1