BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1760012 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01700
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE IS THE PHM (PUMPHEAD MODULE). THE PHM WAS REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER (B)(4) TO REPORT A COLLEAGUE INFUSION PUMP THAT HAD A DAMAGED BATTERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING BAXTER'S REVIEW OF THE EVENT HISTORY, IT WAS DISCOVERED THAT THERE WAS A BATTERY DEPLETED SET ALARM THAT HAD OCCURRED DURING INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN FOR THIS DEVICE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH AN 810:04 FAILURE CODE. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PROGRAMMING/SET-UP IN THE GENERAL PATIENT WARD. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.03.00 WHICH IS CATEGORIZED AS UNREMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1