BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2873461 · Received November 15, 2012

    Report

    Report Number
    1314492-2012-00422
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. REVIEW OF THE DEVICE HISTORY LOG SHOWS MULTIPLE SYSTEM ERROR 345 ALARMS, HOWEVER, DURING THE EVAL, NO SYSTEM ERROR 345 ALARMS WERE OBSERVED. A SYSTEM ERROR 345 OCCURS WHEN THE TEMP REPORTED BY THE UPSTREAM AND DOWNSTREAM THERMISTORS HAVE A DIFFERENCE OF GREATER THAN 10 DEGREES FAHRENHEIT FOR 10 CONSECUTIVE CAM REVOLUTIONS. THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS "BROKE."

    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