BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2943486 · Received January 9, 2013

    Report

    Report Number
    1314492-2013-00015
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER PERFORMED A DEVICE INVESTIGATION AND THE DEVICE IN QUESTION WAS NOT OBSERVED TO POWER ON WITHOUT USER INPUT. THE LINK SWITCHES AND LATCH SWITCHES (UPPER AND LOWER) WERE EVALUATED AND FOUND TO PERFORM AS EXPECTED. THE ON/OFF KEY ON THE PUMP KEYPAD WAS EVALUATED AND FOUND TO PERFORM AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WILL POWER ON WITHOUT USER INPUT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12998 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1