BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3014284 · Received February 19, 2013

    Report

    Report Number
    1314492-2013-00125
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION. UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. ADDITIONAL UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE COMPLETED AND THE DEVICE PERFORMED AS EXPECTED. ADDITIONAL EVENT DETAILS OR PARAMETERS COULD NOT BE OBTAINED FROM THE CUSTOMER; HOWEVER REVIEW OF THE DEVICE HISTORY LOG FROM 01/09/2013 TO 01/18/2013 SHOWS THE PUMP ALARMED FOR A DOWNSTREAM OCCLUSION ON TWO OCCASIONS. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DID NOT ALARM FOR AN OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72526 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1