BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3871391 · Received January 29, 2014

    Report

    Report Number
    1314492-2014-05024
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    November 1, 2013
    Report Date
    January 2, 2014
    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

    MFR REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE EVALUATION DETERMINED THAT THE PUMP FALSELY RECOGNIZING AN OPEN DOOR WAS CAUSED BY A FAILED INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB). AS A RESULT, THE FAILED I/O PCB HAS BEEN REPLACED.

    Description of Event or Problem · 1

    DURING BAXTER'S EVALUATION, THE DEVICE FALSELY RECOGNIZED THAT THE DOOR WAS OPEN, WHEN THE DOOR WAS CLOSED. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62714 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1