BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3170888 · Received May 23, 2013

    Report

    Report Number
    1314492-2013-00637
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 24, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO. (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL AND THEREFORE, AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNK AMOUNT OF SPECTRUM PUMPS ARE ALARMING "UPSTREAM OCCLUSION" WHEN NO OCCLUSION IS PRESENT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER STATED THAT THIS OCCURS MORE FREQUENTLY WITH BLOOD PRODUCTS AND ANTIBIOTICS, AND WHEN MORE THAN 1 PUMP IS DELIVERING TO THE PT. THE CUSTOMER ALSO STATED THAT THIS HAS OCCURRED LENS FREQUENTLY AFTER BAXTER PROVIDED ADD'L TRAINING AND THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228354 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1