BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3181736 · Received June 6, 2013

    Report

    Report Number
    1314492-2013-00713
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. EVALUATION DID NOT CONFIRM THE PUMP SHUT OFF BY ITSELF. THERE WERE NO OCCURRENCES OF "IMPROPER SHUTDOWN" MESSAGES IN THE DEVICE HISTORY LOG. THE HISTORY LOG SHOWS THAT AFTER A SYSTEM ERROR, THE UNIT WAS POWERED OFF BY A USER AS INDICATED IN THE LOG AS "PUMP OFF." THERE IS NO INFORMATION WHICH SUGGESTS A REPORTABLE MALFUNCTION OCCURRED. MANUFACTURER REPORT NUMBER: 1314492-2013-000716 IS RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP SHUTS OFF BY ITSELF. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251950 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1