BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1023082 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-04184
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    October 4, 2005
    Report Date
    October 4, 2005
    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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FAILURE CODE 703 WAS CONFIRMED. THE DEVICE HAS BEEN SEQUESTERED IN THE SERVICE DEPOT PENDING THE APPROVAL OF THE APPROPRIATE REPAIRS. THIS ISSUE IS BEING INVESTIGATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND A FOLLOW-UP MEDWATCH WILL BE GENERATED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE.

    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 CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1