BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2202943 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18407
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 812:02 ON CHANNEL A WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. HOWEVER, DUE TO REFUSAL OF THE ESTIMATE BY THE CUSTOMER, NO ASSIGNABLE CAUSE WAS MADE. THE PUMP WAS RETURNED UNREPAIRED. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING ONE EXCEPTION DURING MANUFACTURING, HOWEVER, THE DEVICE WAS RE-TESTED AND FOUND TO BE PERFORMING AS DESIGNED. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND IS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP WHICH HAD FAILURE CODE 812:02. THIS CONDITION HAS THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    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