BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3062596 · Received March 18, 2013

    Report

    Report Number
    1314492-2013-00256
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 17, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN AMOUNT OF SPECTRUM PUMPS ALARM FOR AN OCCLUSION WHEN NO OCCLUSION IS PRESENT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). THE CUSTOMER STATED THAT THE ALARM IS RESOLVED WHEN THE HEIGHT OF THE PUMP AND IV POLE IS INCREASED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111605 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1