BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2843705 · Received October 26, 2012

    Report

    Report Number
    1314492-2012-00369
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO SIGMA AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. HOWEVER, THERE IS A REASONABLE PROBABILITY THAT THE MALFUNCTION INVOLVES A SHORTING OF THE KEYPAD, WHICH IS CONSIDERED A REPORTABLE EVENT. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN SELECTING THE ABC KEY, M IS DISPLAYED. IT WAS ALSO REPORTED THAT THE #5 KEY IS NOT WORKING CORRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1