BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2943475 · Received January 8, 2013

    Report

    Report Number
    1314492-2013-00014
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 12, 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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BAXTER DEVICE EVAL 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 #2 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (EG, 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 (B)(4)). FURTHER EVAL REVEALED VISIBLE KEYPAD DAMAGE AT THE #2, #5, AND #8 KEYS CAUSED BY AN EXTERNAL FORCE. BAXTER'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD ON A PUMP WAS INOPERABLE. THE CUSTOMER STATED THAT THE "KEYPAD DOUBLE TAPS EVERY TIME A KEY IS PRESSED (IE, PUSHING "7"), "77" APPEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9612 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1