BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3203727 · Received June 26, 2013

    Report

    Report Number
    1314492-2013-00879
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL. THE CUSTOMER CANNOT IDENTIFY THE DEVICE INVOLVED IN THE EVENT, AND IT WAS NEVER REMOVED FROM SERVICE. IF THE DEVICE IS IDENTIFIED AND RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SPECTRUM INFUSION PUMP DOES NOT HAVE THE CAPABILITY TO DETECT INFILTRATION EVENTS, AND IS COMMUNICATED IN THE SPECTRUM OPERATORS MANUAL AS "THE PUMP WAS NOT DESIGNED NOR IS INTENDED TO DETECT INFILTRATIONS OR EXTRAVASATIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DID NOT ALARM WHEN A PT'S IV HAD INFILTRATED. THE CUSTOMER STATED THAT THERE WAS NO PROLONGED HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289467 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention