BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2863127 · Received November 1, 2012

    Report

    Report Number
    1314492-2012-00385
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 2, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SIGMA DEVICE EVALUATION FOUND ALL KEYS (OTHER THAN THE 1ST AND 2ND SOFT KEYS) TO BE INOPERABLE. AN AUTOMATIC AND CONSTANT OUTPUT OF THE 3RD SOFT KEY WAS ALSO OBSERVED CAUSED BY A FAILED INPUT/OUTPUT PRINTED CIRCUIT BOARD. THIS FAILURE MODE DOES NOT PROVIDE ANY USER OPPORTUNITIES TO PROGRAM DELIVERY PARAMETERS NOR START AN INFUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A KEYPAD ON A PUMP WAS INOPERABLE; THAT ONLY THE ON/OFF KEY IS WORKING, AND THAT THE PUMP TURNS ON AND CONSTANTLY BEEPS. THE CUSTOMER ALSO STATED THAT THERE WAS NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1