BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2923032 · Received December 27, 2012

    Report

    Report Number
    1314492-2012-00534
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO SIGMA 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 A PUMP OVER INFUSED MIDAZOLAM TO A PT (INFUSION AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER STATED THAT THE MEDICATION WAS PROGRAMMED TO INFUSE OVER SEVERAL HOURS, BUT THE INFUSION WAS COMPLETE IN LESS THAN ONE HOUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1