BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1233106 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-05647
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    April 1, 2007
    Report Date
    April 3, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 814:04. IT IS UNKNOWN WHEN THIS FAILURE CODE OCCURRED. EVALUATION SUMMARY: DURING PRODUCT EVALUATION, THE AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) VALUES WERE FOUND TO BE OUT OF SPECIFICATION. FAILURE CODE 814:04 WAS MANIFESTED AS A RESULT OF THIS CONDITION. THE AIL PCB COULD NOT BE CALIBRATED, THEREFORE THE PUMP HEAD MODULE WAS REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD (AIL PCB) WAS FOUND TO BE OUT OF SPECIFICATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1