BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2922808 · Received December 28, 2012

    Report

    Report Number
    1314492-2012-00544
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 3, 2012
    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). THE SIGMA DEVICE EVAL FOUND THE #2 AND #3 KEYS TO BE INOPERABLE. IT WAS OBSERVED THAT WHEN THE #2 KEY IS SELECTED, AN AUTOMATIC OUTPUT OF THE "OK" KEY WILL OCCUR INSTEAD OF THE SELECTED KEY'S FUNCTION. IT WAS ALSO OBSERVED THAT WHEN THE #3 KEY IS SELECTED, AN AUTOMATIC OUTPUT OF THE "RUN/STOP" KEY WILL OCCUR INSTEAD OF THE SELECTED KEY'S FUNCTION. ALL OTHER KEYS PERFORMED AS EXPECTED. FURTHER EVAL DETERMINED THIS OUTPUT ANOMALY TO BE CAUSE BY A FAILED KEYPAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE #2 KEY ON A PUMP KEYPAD IS PRESSED, AN AUTOMATIC OUTPUT OF THE DOWN ARROW KEY (3RD SOFT KEY) IS DISPLAYED INSTEAD OF THE SELECTED KEY'S FUNCTION.

    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