BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3780060 · Received January 6, 2014

    Report

    Report Number
    1314492-2014-00843
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 9, 2013
    Manufacturer
    BAXTER HEALTHCARE COPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 MULTIPLE DEVICES ALARMED SYSTEM ERROR 322. THE CUSTOMER REPORTED THAT A HIGH VOLUME OF PUMPS PER WEEK WERE EXPERIENCING THIS ERROR. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8214 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE COPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1