BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2896695 · Received November 21, 2012

    Report

    Report Number
    1314492-2012-00451
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SIGMA DEVICE EVAL FOUND THE OK, RUN/STOP, #3, #4, #5, #6, #7, #8, AND #9 KEYS TO BE INOPERABLE. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE RUN/STOP KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (EG, "WHEN THE #1 KEY IS PRESSED 1 FOLLOWED BY RUN/STOP WILL BE ENTERED"). SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "OK" KEY ON A PUMP KEYPAD IS 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