BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3112245 · Received May 3, 2013

    Report

    Report Number
    1314492-2013-00490
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED SYMPTOM OF "WILL NOT CONNECT" COULD NOT BE REPRODUCED. UNIT WAS TESTED WITH THE UNIT PASSING. ADDITIONALLY, THE PUMP WAS COUPLED WITH A KNOWN GOOD WIRELESS BATTERY MODULE, WITH THE BAXTER (B)(4) GATEWAY CONFIGURATION INSTALLED, MAKING SURE THE BATTERY AND PUMP ARE ABLE TO COMMUNICATE WITH THE BAXTER (B)(4) GATEWAY AND RECEIVE THE IP ADDRESS AND GATEWAY INFORMATION FROM THE BAXTER (B)(4) NETWORK. THE DEVICE WILL BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED A PUMP WOULD NOT CONNECT TO THE CUSTOMER'S NETWORK. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195596 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1