BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4850583 · Received June 15, 2015

    Report

    Report Number
    1314492-2015-06820
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 21, 2015
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR BAXTER FOR EVALUATION. 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 A SPECTRUM PUMP FAILED TO DELIVER THE PROGRAMMED AMOUNT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). IT WAS REPORTED THERE WERE 300 MILLILITERS REMAINING OF A 1 LITER INFUSION. IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389548 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1