BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3220672 · Received June 25, 2013

    Report

    Report Number
    1314492-2013-00849
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION COULD NOT CONFIRM OR REPRODUCE AN UNDER INFUSION. A FLOW RATE TEST WAS PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. ADDITIONAL FLOW RATE TESTS WERE ALSO COMPLETED WITH THE DEVICE PERFORMING WITHIN SPECIFICATION. THE REPORTED PARAMETERS ARE UNCLEAR AND NO CLARIFICATION COULD BE OBTAINED FROM THE CUSTOMER; ADDITIONALLY, NO DEVICE MALFUNCTION COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE UNDER INFUSED TPN TO A PT. THE DEVICE WAS PROGRAMMED TO DELIVER "25 ML, IN 4 HOURS 50 ML, IN 4 MORE HOURS 75 ML" AND ONLY DELIVERED "25 ML, RAN FOR 8 HOURS 200 ML." IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287193 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1