BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2132828 · Received June 17, 2011

    Report

    Report Number
    6000001-2011-07942
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF CONSTANT UPSTREAM OCCLUSION ALARM WAS CONFIRMED THROUGH EVALUATION DUE TO A FAULTY PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    A BAXTER SERVICE TECHNICIAN REPORTED FINDING A COLLEAGUE INFUSION PUMP WITH A CONSTANT UPSTREAM OCCLUSION ALARM DURING THE ACCURACY TEST. THIS EVENT OCCURRED DURING PRODUCT EVALUATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1