BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL CXEPUMP V1.7

    MDR report key: 2060525 · Received April 18, 2011

    Report

    Report Number
    6000001-2011-02920
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER EVALUATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH SCREEN DISPLAYING "PUMP MAY STOP UNEXPECTEDLY", WAS CONFIRMED IN THE PUMP'S EVENT HISTORY BUT NOT DUPLICATED DURING PRODUCT EVALUATION. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, NO ASSIGNABLE CAUSE WAS PROVIDED DURING PRODUCT EVALUATION AND NO REPAIR WAS NECESSARY FOR THE REPORTED CONDITION. ADDITIONAL INFORMATION: THIS INVOLVED A COLLEAGUE VERSION 1.7 INFUSION PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 8.11.00. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A COLLEAGUE INFUSION PUMP THAT WAS RETURNED TO BAXTER TECHNICAL SERVICES AND THE SCREEN DISPLAYED, "PUMP MAY STOP UNEXPECTEDLY," DURING BIO MED TESTING. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE SINGLE CHANNEL CXEPUMP V1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1