BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3003428 · Received February 13, 2013

    Report

    Report Number
    1314492-2013-00099
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION FOR 24 HRS AND FOUND ALL KEYS TO PERFORM AS EXPECTED AND NO KEYS RESULTED IN AN INCORRECT RESPONSE OR DOUBLE ENTRY. THE KEYPAD WAS DELAMINATED AND EXAMINED UNDER A MICROSCOPE AND NO FAILURES WERE EVIDENT ON THE KEYPAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE OK KEY ON A PUMP KEYPAD IS SELECTED, THE DEVICE ¿SHUTS OFF;¿ AND THE 3RD SOFT KEY AND THE #2 KEY ARE INOPERABLE. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64216 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1