BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1930932 · Received December 16, 2010

    Report

    Report Number
    6000001-2010-05871
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF A CONSTANT, FALSE AIR ALARM ON CHANNEL A WAS CONFIRMED THROUGH EVALUATION DUE TO A FAULTY CHANNEL A AIR-IN-LINE PRINTED CIRCUIT BOARD. THE CHANNEL A PUMPHEAD MODULE WAS REPLACED TO CORRECT THE REPORTED CONDITION. (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 (B)(4). THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "AIR IN LINE-FALSE ALARM". (B)(4).

    Description of Event or Problem · 1

    DURING DEVICE EVALUATION BY BAXTER, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE A CONSTANT, FALSE AIR ALARM ON CHANNEL A. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY OR MEDICAL INTERVENTION IS RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.03.00 CATEGORIZED AS UNREMEDIATED.

    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