BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2923033 · Received December 27, 2012

    Report

    Report Number
    1314492-2012-00533
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND FOUND THE COLUMN FOUR AND ROW FOUR KEYS (THE 4TH SOFT KEY, "RUN/STOP" KEY, #3, #6, #9, (.), #4, AND #5 KEYS) TO BE INOPERABLE CAUSED BY A FAILED KEYPAD. THIS FAILURE MODE DOES NOT PROVIDE ANY USER OPPORTUNITIES TO START AN INFUSION. ALL THE REMAINING KEYS FUNCTIONED AS EXPECTED AND NO KEYS RESULTED IN AN INCORRECT RESPONSE OR DOUBLE ENTRY. SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND FOUND THE COLUMN FOUR AND ROW FOUR KEYS (THE 4TH SOFT KEY, "RUN/STOP" KEY, #3, #6, #9, (.), #4, AND #5 KEYS) TO BE INOPERABLE CAUSED BY A FAILED KEYPAD. THIS FAILURE MODE DOES NOT PROVIDE ANY USER OPPORTUNITIES TO START AN INFUSION. ALL THE REMAINING KEYS FUNCTIONED AS EXPECTED AND NO KEYS RESULTED IN AN INCORRECT RESPONSE OR DOUBLE ENTRY. SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A KEYPAD ON A PUMP DOUBLE BEEPS, EXCEPT FOR KEYS #7, #8, AND #9. THE CUSTOMER STATED THERE WAS NO PT INJURY. A HANDWRITTEN NOTE ATTACHED TO THE PUMP WHEN IT CAME BACK TO THE MFR FOR REPAIR STATES "KEYPAD BUTTONS 3, 4, 5, 6 INOPERABLE."

    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