BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3003404 · Received February 13, 2013

    Report

    Report Number
    1314492-2013-00097
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    1314492-080712-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAXTER DEVICE EVALUATION FOUND THE RUN/STOP, #0, #1, #2, #4, #5, #7, #8 AND (.) 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 #3 KEY IS PRESSED THE #3 FOLLOWED BY THE RUN/STOP KEY WILL BE ENTERED). BAXTER'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON/OFF, SETUP, OK, AND RUN/STOP KEYS ON A PUMP KEYPAD ARE INOPERABLE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63950 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1