BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2953979 · Received January 15, 2013

    Report

    Report Number
    1314492-2013-00029
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 18, 2012
    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
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO (B)(4). THE BAXTER DEVICE EVALUATION FOUND THE #8, AND #9 KEYS TO BE INOPERABLE. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE #9 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE #1 KEY IS PRESSED 19 WILL BE DISPLAYED. WHEN IN ALPHABETIC MODE AND THE "ABC" KEY IS SELECTED, AY WILL BE DISPLAYED INTERFERING WITH THE MDL DRUG SEARCH). BAXTER'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP KEYPAD IS DEFECTIVE. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22197 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1