BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3192363 · Received June 18, 2013

    Report

    Report Number
    1314492-2013-00803
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER REC'D AND EVALUATED THE DEVICE IN QUESTION. THE FAILED DOWNSTREAM OCCLUSION TEST COULD NOT BE REPRODUCED DURING THE EVAL. THE PUMP WAS FOUND TO BE WITHIN SPECIFICATION AND NO MALFUNCTION COULD BE IDENTIFIED. A DOWNSTREAM OCCLUSION TEST WAS PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. ADD'L FLOW RATE TESTS WERE PERFORMED WITH THE UNIT PASSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP FAILED TO ALARM FOR A DOWNSTREAM OCCLUSION DURING A PREVENTIVE MAINTENANCE TEST. IT WAS ALSO REPORTED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277443 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1