BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1832899 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03194
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS CONFIRMED AND DUPLICATED FOR THE REPORTED CONDITION OF 812:02 DUE TO A DEFECTIVE PHM (PUMP HEAD MODULE). THE PHM WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    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. THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. BAXTER'S INVESTIGATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4)

    Additional Manufacturer Narrative · 1

    THERE IS AN ONGOING CAPA INVESTIGATION, (B)(4), ASSOCIATED WITH THIS REPORT. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS RELATED TO THE REPORTED CONDITION.(B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.06.00 CATEGORIZED AS UNREMEDIATED. (B)(4).

    Description of Event or Problem · 1

    BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE DEVICE FOR FAILURE CODE 812:02. THE DEVICE WAS REPAIRED ON-SITE. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. UPON REVIEW OF THE EVENT HISTORY BY BAXTER, IT WAS FOUND THAT FAILURE CODE 812:02 CAUSED AN INTERRUPTION OF DELIVERY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS NOT AVAILABLE AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1