BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3780449 · Received January 7, 2014

    Report

    Report Number
    1314492-2014-01132
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 10, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER IS CONTINUING TO INVESTIGATE THE REPORTED EVENT. WHEN THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD A SYSTEM ERROR 320 WHILE IN USE ON A PT. THIS ALARM WAS REPORTED TO HAVE INTERRUPTED THERAPY FOR AN UNK AMOUNT OF TIME. IT WAS ALSO REPORTED THAT THERE WAS NO KNOWN PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11599 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1