BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECTRUM INFUSION PUMP

    MDR report key: 3061397 · Received March 26, 2013

    Report

    Report Number
    1314492-2013-00295
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION COULD NOT CONFIRM THE PUMP TO POWER OFF WITHOUT USER INPUT. THE PUMP WAS RECEIVED INOPERABLE CAUSED BY A FAILED INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB). REVIEW OF THE DEVICE HISTORY LOG COULD NOT IDENTIFY ANY IMPROPER SHUTDOWN EVENTS. THE FAILED I/O PCB WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING, A PUMP WOULD POWER OFF WITHOUT USER INPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124614 ECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1