BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2861217 · Received November 2, 2012

    Report

    Report Number
    1314492-2012-00392
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SIGMA DEVICE EVALUATION FOUND THE #2, #3, #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 #3 KEY WILL OCCUR FOLLOWING THE SELECTION KEY'S FUNCTION (E.G. WHEN THE #1 KEY IS PRESSED 13 WILL BE DISPLAYED. WHEN IN ALPHABETIC MODE AND THE ABC KEY IS SELECTED, AG WILL BE DISPLAYED INTERFERING WITH THE MDL DRUG SEARCH). SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP KEYPAD IS INOPERABLE. THE CUSTOMER STATED THAT A FAILURE OF THE #3 (GHI) KEY WAS OBSERVED. IT WAS ALSO REPORTED THAT THE KEYS ON ROW 2 AND 3 (#0, #1, #2, #3, #4, #5, #6 AND ".") ON THE KEYPAD ARE UNRESPONSIVE.

    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