BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1946321 · Received January 4, 2011

    Report

    Report Number
    6000001-2011-00020
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    September 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: THE REPORTED CONDITION OF OVERINFUSED WAS NOT CONFIRMED OR REPRODUCED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS NOT IDENTIFIED. NO REPAIRS HAVE BEEN PERFORMED DUE TO THE CUSTOMER'S REFUSAL OF ESTIMATE, NO FURTHER CORRECTION WAS MADE CONCERNING THIS EVENT AND THE PUMP WAS RETURNED UNREPAIRED. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. 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. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WHICH OVERINFUSED IN THE NURSING DEPARTMENT DURING SET-UP. ACCORDING TO THE FACILITY, THE PUMP INFUSED AT A HIGHER RATE THAN PROGRAMMED WHEN IT WAS TESTED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1