BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,COLLEAGUE CXE SINGLECHANNEL COLOUR FRENCH LOANER

    MDR report key: 1981101 · Received February 8, 2011

    Report

    Report Number
    6000001-2011-00715
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER'S FACILITY. THE CONDITION OF DEPLETED BATTERY ALARM WAS CONFIRMED THROUGH THE EVENT HISTORY DUE TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE 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)

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A BATTERY ISSUE. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. IT IS UNKNOWN IF PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A DEPLETED BATTERY ALARM WHICH INTERRUPTED DELIVERY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.63.92 CATEGORIZED AS REMEDIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1