BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2896705 · Received November 21, 2012

    Report

    Report Number
    1314492-2012-00455
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. IT WAS OBSERVED THAT THE SYSTEM ERROR 305 WAS CAUSED BY A FAILED INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB). REVIEW OF THE DEVICE HISTORY LOG SHOWS MULTIPLE SYSTEM ERROR 305 ALARMS. ERROR CODE 305 OCCURS WHEN THE FORCE SENSOR READING IS BELOW 50% OF THE NO-TUBE CALIBRATED READING CONTINUOUSLY FOR 1 MINUTE WHILE THE PUMP IS RUNNING. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP IN THE FACILITY'S CCU CARE AREA ALARMED FOR A SYSTEM ERROR 305.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1