BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4655745 · Received March 27, 2015

    Report

    Report Number
    1314492-2015-04364
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 4, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SUPPLIED PHOTOGRAPHS OF THE DEVICE HISTORY LOG ON THE DEVICE IN QUESTION. THE HISTORY LOG SHOWS THAT THE PROGRAMMED RATE OF DELIVERY WAS 50 ML/HR (NOT 100 ML/HR AS REPORTED) WHICH WOULD RESULT IN THE REPORTED DELIVERED VOLUME OF 150 ML AFTER 3 HOURS. THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL. THEREFORE, AN EVAL 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 DURING THERAPY IN THE MEDICAL SURGICAL CARE AREA. THE CUSTOMER STATED THAT THE PUMP WAS PROGRAMMED TO INFUSE AT A RATE OF 100 ML/HR AND AFTER 3 HOURS ONLY 150 ML HAD INFUSED. THE VOLUME TO BE INFUSED WAS 300 ML (MEDICATION UNK). IT WAS ALSO REPORT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204885 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1