BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2843623 · Received October 25, 2012

    Report

    Report Number
    1314492-2012-00366
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVAL THE DEVICE IN QUESTION. REVIEW OF THE HISTORY LOG SHOWS THAT THE PUMP ALARMED "DOOR NOT FULLY LATCHED." FURTHER EVAL FOUND THAT THIS WAS DUE TO A LOOSE LINK SCREW. WHEN THE SCREW WAS TIGHTENED, THE DEVICE PERFORMED AS EXPECTED. IT WAS ALSO REPORTED THAT A PUMP WOULD NOT DISPLAY THE "CHECK FLOW" SCREEN AFTER THE START OF AN INFUSION. THE SPECTRUM PUMP WILL NOT DISPLAY THE "CHECK FLOW" PROMPT IN AN INFUSION IS PROGRAMMED UNDER A CARE AREA WHICH CONTAINS "ANESTHESIA" OR "OPERATING ROOM" IN THE NAME. REVIEW OF THE HISTORY LOG SHOWS THAT THE CUSTOMER RAN INFUSIONS FROM THE CARE AREA "CVICU AND CV OPERATING ROOM". THEREFORE, THE CHECK FLOW SCREEN WOULD NOT HAVE BEEN DISPLAYED AT THE START OF THE INFUSIONS. NO MALFUNCTION WAS IDENTIFIED AND SIGMA DOES NOT CONSIDER THIS A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DOOR IS DIFFICULT TO CLOSE, AND THAT THE "CHECK FLOW" PROMPT DOES NOT DISPLAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1