BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2843732 · Received October 26, 2012

    Report

    Report Number
    1314492-2012-00379
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SIGMA DEVICE EVALUATION FOUND THE #2, #4, #5, #6, #7, #8, #9, AND (.) KEYS TO BE INOPERABLE. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE #2 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE #1 KEY IS PRESSED 12 WILL BE DISPLAYED. WHEN IN ALPHABETIC MODE AND THE ABC KEY IS SELECTED, AD WILL BE DISPLAYED INTERFERING WITH THE MDL DRUG SEARCH). SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SIGMA DEVICE EVALUATION CONFIRMED THAT THE COMPLAINT "DOOR IS HARD TO CLOSE WITH A LOADED IV SET" WAS CAUSED BY CUSTOMER DAMAGE TO THE DOOR HOOKS. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR PATIENT INJURY THAT COULD RESULT FROM THE DOUBLE OUTPUT OF THE KEYPAD. THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP STATED "KEYPAD 3RD + 4TH ROW". IT WAS ALSO REPORTED THAT THE DOOR IS HARD TO CLOSE WITH A LOADED IV SET.

    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