BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1850666 · Received October 1, 2010

    Report

    Report Number
    6000001-2010-03718
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 15, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF FAILURE CODE 810:11WAS CONFIRMED, BUT NOT DUPLICATED DUE TO AN OUT OF CALIBRATION AIL PCB (AIR-IN-LINE PRINTED CIRCUIT BOARD). THE AIL PCB WAS RECALIBRATED TO CORRECT THE REPORTED CONDITION. (B)(4).

    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).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION DEVICE THAT NEEDS REPAIR. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.03.00 CATEGORIZED AS UNREMEDIATED. DURING REVIEW OF THE EVENT HISTORY, IT WAS DETERMINED THAT THE REPORTED CONDITION IS FAILURE CODE 810:11 (X1) ON CHANNEL C WHICH OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED, A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. ANOTHER PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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