BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3222057 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01025
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 7, 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). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. THE EVALUATION CONFIRMED THE KEYS ON COLUMN 3 (OK, #2, #5 AND #8) TO BE ACTING AS THE COLUMN 4 KEYS (RUN/STOP, #3, #6 AND #9). THIS DOES NOT ALLOW THE USER TO PROGRAM OR START AN INFUSION. ALL OTHER KEYS PERFORMED AS EXPECTED. THE FAILED KEYPAD WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS AN INOPERABLE KEYPAD. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308172 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1