BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3071221 · Received April 9, 2013

    Report

    Report Number
    1314492-2013-00369
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 11, 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
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION CONFIRMED THE 3RD SOFT KEY, ON/OFF, SETUP, OK RUN/STOP, #0, #1, #2, #3, #4, #5, #6, #7, #8, #9 AND (.) KEY TO BE INOPERABLE. WHEN THE 1ST OR 2ND SOFT KEY IS SELECTED, AN AUTOMATIC OUTPUT OF THE 3RD SOFT KEY IS SELECTED, AN AUTOMATIC OUTPUT OF THE 3RD SOFT KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE 1ST SOFT KEY IS PRESSED, THE 1ST SOFT KEY FOLLOWED BY THE 3RD SOFT KEY WILL BE DISPLAYED). THE KEYPAD WAS REPLACED. BAXTER'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 DEVICE WAS DROPPED AND DAMAGED. DURING BAXTER'S EVALUATION, A KEYPAD ANOMALY WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148101 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1