BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221513 · Received July 3, 2013

    Report

    Report Number
    1314492-2013-00997
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVAL COULD NOT REPRODUCE THE REPORTED SYMPTOM. THE DEVICE PASSED FLOW RATE TESTING USING PROGRAMMED EVENT PARAMETERS AS FOUND IN THE HISTORY LOG (RATE: 94.3 ML/HR), AS WELL AS PER THE SPECTRUM PM PROCEDURE. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN SPEC IN RELATION TO THE REPORTED SYMPTOM. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP OVER INFUSED TPN (PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER STATED THAT THE INFUSION ENDED AT 9:00, WHEN IT WAS SUPPOSED TO END AT 13:00 THE CUSTOMER STATED THE EVENT OCCURRED AT (B)(6). IT WAS ALSO REPORTED THAT THE PT CYCLED DOWN WITH A 10% DEXTROSE IN WATER SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303582 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1