BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3003407 · Received February 13, 2013

    Report

    Report Number
    1314492-2013-00096
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION AND A FLOW RATE TEST WAS PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE AND THE DEVICE WAS 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 HR) WITH THE UNIT PASSING. REVIEW OF THE HISTORY LOG SUPPORTS THE REPORTED EVENT PARAMETERS; HOWEVER NO MALFUNCTION COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS PROGRAMMED TO DELIVER 1000ML OF FLUID AT A RATE OF 100ML/HR, HOWEVER IT WAS OBSERVED THAT ¿THE IV APPEARED TO DRIP AT AN EXTREMELY HIGH RATE (MEDICATION UNK). THE INFUSION WAS STOPPED AND THE DEVICE WAS REPLACED. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY. THE CUSTOMER TESTED THE DEVICE AT 100ML/HR TO DELIVER 1000ML AND 240ML/HR TO DELIVER 20ML. THE DEVICE PASSED BOTH TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63951 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1