BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3192382 · Received June 18, 2013

    Report

    Report Number
    1314492-2013-00800
    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
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE DEVICE EVAL CONFIRMED THE OK, #0, #1, #2, #3, (.), #4, #5, #6, #7, #8, AND #9 KEY TO BE INOPERABLE CAUSED BY A FAILED KEYPAD. IT WAS OBSERVED THAT WHEN REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE OK KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION. THE KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM WAS EXPERIENCING INCORRECT ENTRIES. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276205 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1