BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMERTIC INFUSION PUMP

    MDR report key: 1203750 · Received October 9, 2008

    Report

    Report Number
    6000001-2008-00607
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF A PUMP WITH AN INOPERABLE OPEN BUTTON WAS CONFIRMED DURING PRODUCT EVALUATION. INSPECTION OF THE DEVICE FOUND THE PUMP HEAD MODULE KEYPAD TO BE DEFECTIVE. THE PUMP HEAD MODULE KEYPAD WAS THEREFORE REPLACED TO ADDRESS THE REPORTED CONDITION. THE DEVICE WAS TESTED AND RETURNED WITHIN SPECIFICATION. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH AN INOPERABLE OPEN BUTTON. THIS PROBLEM WAS IDENTIFIED DURING BIO-MED TESTING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMERTIC INFUSION PUMP 80 FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1