BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM PUMP

    MDR report key: 1730003 · Received June 15, 2010

    Report

    Report Number
    1730003
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 14, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OCCLUSION ALARM DOES NOT SOUND AND UNIT DOES NOT ACKNOWLEDGE FURTHER OCCLUSIONS, IF THE "RUN/STOP" KEY IS PRESSED BEFORE CLEARING AN INITIAL OCCLUSION.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THIS PUMP ALLOWS THE USER TO PRESS THE RUN/STOP KEY PRIOR TO CLEARING AN OCCLUSION. OTHER BRAND PUMPS DO NOT ALLOW THE USER TO STOP THE ALARM PRIOR TO CLEARING AN OCCLUSION.====================== MANUFACTURER RESPONSE FOR IV PUMP, SPECTRUM PUMP======================THAT THE DEVICE IS SAFE TO USE FOR PATIENTS AND APPROVED BY THE FDA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM PUMP IV PUMP FRN SIGMA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *