BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,COLLEAGUE SINGLE CHANNELCOLOUR

    MDR report key: 1970194 · Received January 25, 2011

    Report

    Report Number
    6000001-2011-00430
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    May 24, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF BATTERY DEPLETED SET CONFIRMED THROUGH THE EVENT HISTORY. THE CONDITION IS DUE TO DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND HARNESS WERE REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4). THE DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER FROM BAXTER (B)(6) ORIGINALLY REPORTED DAMAGED BATTERY ON A COLLEAGUE INFUSION PUMP. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(6) PERSONNEL, THE PUMP WAS FOUND TO HAVE EXPERIENCED A BATTERY DEPLETED SET WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.92 CATEGORIZED AS REMEDIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1