BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 5636563 · Received May 6, 2016

    Report

    Report Number
    1314492-2016-02815
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    April 4, 2016
    Report Date
    April 14, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS NOT RETURNED TO 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 DELIVERED AT A LOWER RATE OR VOLUME THAN PROGRAMMED (UNDER INFUSION) OF PLATELETS DURING THERAPY IN UNIT 57 ONCOLOGY, HEMATOLOGY, BMT. THE CUSTOMER REPORTED THAT THE PUMP WAS SET TO INFUSE 347 MLS OF PLATELETS AT 833 ML/HR. HOWEVER, WHEN THE PUMP INDICATED THE INFUSION WAS COMPLETE, THE REPORTER WAS REQUIRED TO ADD 98 MLS OF FLUID TO BE INFUSED. THE SET USED WITH THE PUMP WAS "BLOOD Y-TYPE IV ADMINISTRATION SET W/ 170-260 MICRON FILTER, PRODUCT CODE JC7751, LOT # UNKNOWN." IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION PROVIDED AS A RESULT OF THIS UNDER INFUSION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292132 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1