BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3032160 · Received March 7, 2013

    Report

    Report Number
    1314492-2013-00206
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REC'D AND EVALUATED BY BAXTER. THE DEVICE WAS EVALUATED FOR 48 HOURS AND AN IMPROPER SHUTDOWN OR A SYSTEM ERROR 345 ALARM COULD NOT BE CONFIRMED. REVIEW OF THE DEVICE HISTORY LOG COULD NOT BE CONFIRM AN IMPROPER SHUTDOWN, HOWEVER, ONE SYSTEM ERROR 345 OBSERVED ON (B)(6) 2013. A SYSTEM ERROR 345 OCCURS WHEN THE TEMPERATURE REPORTED BY THE UPSTREAM AND DOWNSTREAM THERMISTORS HAVE A DIFFERENCE OF GREATER THAN 10 DEGREES FAHRENHEIT FOR 10 CONSECUTIVE CAM REVOLUTIONS. IT IS LIKELY THAT OPERATING THE DEVICE IN 15 DEGREES FAHRENHEIT WOULD CONTRIBUTE TO A SYSTEM ERROR 345 ALARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP POWERED OFF WITHOUT USER INPUT DURING AN INFUSION (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER ALSO STATED THAT THE PUMP ALARMED FOR A SYSTEM ERROR 345 WHEN THE PT WAS OUTSIDE AND THE TEMPERATURE WAS APPROXIMATELY 15 DEGREES FAHRENHEIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98343 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 SPECTRUM STANDARD BATTERY MODULE