BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3063119 · Received February 27, 2013

    Report

    Report Number
    1314492-2013-00158
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 29, 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
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO: (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE EVAL CONFIRMED THE RUN/STOP, (.), #0, #1, #2, #4, #5, #7 AND #8 KEYS TO BE INOPERABLE CAUSED BY A FAILED KEYPAD. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE RUN/STOP KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE RUN/STOP KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE #3 KEY IS PRESSED THE #3 KEY FOLLOWED BY RUN/STOP WILL BE ENTERED). THIS DOES NOT ALLOW THE USER TO PROGRAM OR START AN INFUSION. THE FAILED KEYPAD WAS REPLACED. BAXTER'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING BAXTER'S EVAL, IT WAS OBSERVED THAT THE KEYPAD DID NOT PERFORM AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84400 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1