BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2990236 · Received February 6, 2013

    Report

    Report Number
    1314492-2013-00076
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION AND A FLOW RATE TEST WAS PERFORMED PER THE SPECTRUM PREVENTATIVE MAINTENANCE PROCEDURE AND THE DEVICE WAS FOUND TO DELIVER WITHIN SPECIFICATION. THE DEVICE ALSO PASSED ADD¿L FLOW RATE TESTS, INCLUDING A TEST PROGRAMMED AT THE REPORTED EVENT PARAMETERS. 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 212 ML OF CALCIUM GLUCONATE 1 GRAM AND MAGNESIUM SULFATE 1 GRAM IN D5W AT A RATE OF 283ML/HR. THE CUSTOMER STATED THAT WHEN THE PUMP ALARMED FOR INFUSION COMPLETE, THE MEDICATION CONTAINER WAS OBSERVED TO BE HALF FULL. THE CUSTOMER STATED THAT THE PUMP WAS REPLACED AND THE INFUSION WAS COMPLETED AS PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51217 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 BAXTER IV SET (B)(4)