BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3061380 · Received March 26, 2013

    Report

    Report Number
    1314492-2013-00291
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION WAS UNABLE TO CONFIRM AN OVER DELIVERY. REVIEW OF THE DEVICE HISTORY LOG SHOWS THAT THE INFUSION WAS PROGRAMMED TO DELIVER AT A RATE OF 75 ML/HR. A FLOW RATE TEST WAS PERFORMED WITH THE DEVICE IN QUESTION, PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE AND FOUND TO DELIVER WITHIN SPECIFICATION. AN ADDITIONAL FLOW RATE TEST WAS PERFORMED USING THE EVENT INFUSION PARAMETERS FOUND IN THE HISTORY LOG (FOR A PERIOD OF ONE HOUR) WITH THE UNIT PASSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE OVER INFUSED FLUID TO A PT. THE PUMP WAS PROGRAMMED TO DELIVER 600 ML AT A RATE OF 70 ML/HR (MEDICATION UNK). THERE WAS NO REPORT OF INJURY TO THE PT AS A RESULT OF THE OVER INFUSION. WITH THE LIMITED INFORMATION OBTAINED FROM THE CUSTOMER, THE ALLEGED INFUSION INACCURACY IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123185 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1