BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1832720 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-00815
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 14, 2006
    Report Date
    December 14, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON (B)(4) 2007. EVALUATION SUMMARY: THE DEVICE WAS EVALUATED AT A BAXTER SERVICE CENTER. THE REPORTED CONDITION OF FAILURE CODE 703 WAS CONFIRMED. THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS FOUND TO BE NOT FUNCTIONING WITHIN SPECIFICATION WHICH CAUSED THE FAILURE TO OCCUR. THE CIRCUIT BOARD WAS REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL. 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 MDQ-CAPA-91.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FROM CUSTOMER FOR SERVICE. DURING SERVICE BY BAXTER TECHNICIAN, THE DEVICE WAS FOUND TO HAVE FAILURE CODE 703 IN THE EVENT HISTORY. CUSTOMER REPORTED THERE WERE NO PATIENT INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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