BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3191190 · Received June 14, 2013

    Report

    Report Number
    1314492-2013-00791
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    1314492-080712-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE DEVICE EVALUATION CONFIRMED THE FOLLOWING KEYS ARE INOPERABLE: (.), #2, #3, AND #4, #5, #8 AND #9 KEYS CAUSED BY A FAILED KEYPAD. 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). THE FAILED KEYPAD WAS REPLACED. BAXTER HAS INITIATED A CAPA TO INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMPS KEYPAD WAS INPUTTING DOUBLE VALUES WHEN A SINGLE KEY IS PRESSED. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272380 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1