BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240943 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04213
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    January 27, 2007
    Report Date
    January 27, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION OF THE DEVICE WAS COMPLETED BY THE BAXTER REPAIR TECHNICIAN. INSPECTION OF THE DEVICE REVEALED THE AIL PCB WAS NOT PROPERLY CALIBRATED AND THEREFORE CAUSED THE FAILURE CODE 810:11. THE AIL PCB WAS RECALIBRATED AND THE DEVICE WAS TESTED BY THE REPAIR TECHNICIAN.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO BAXTER FOR SERVICE. DURING TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A CALIBRATION CONDITION WITH THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB). ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1