BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3192405 · Received June 18, 2013

    Report

    Report Number
    1314492-2013-00805
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    1314492-080712-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVAL FOUND THE FOLLOWING KEYS INOPERABLE: OK, RUN/STOP, (.), #0, #1, #2, #4, #5, #7, AND #8 KEY CAUSED BY A FAILED KEYPAD. THIS FAILURE MODE DOES NOT PROVIDE ANY USER OPPORTUNITIES SELECT CARE AREA, ENTER DELIVERY PARAMETERS, OR START AN INFUSION. WHEN ANY OF THE REMAINING FUNCTIONAL KEYS ARE PRESSED AND AUTOMATIC OUTPUT OF THE RUN/STOP KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION. THE FAILED KEYPAD WAS REPLACED. BAXTER INITIATED A CAPA TO FURTHER INVESTIGATE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL OF THE KEYS ON THE KEYPAD WERE NOT FUNCTIONAL EXCEPT FOR THE "3,6, AND 9 KEY." IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277454 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1