BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2243355 · Received September 12, 2011

    Report

    Report Number
    6000001-2011-23891
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS DETERMINED TO BE USE/USER ERROR. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO ABNORMALITY WAS OBSERVED IN THE MANUFACTURING OF THIS DEVICE. A SERVICE HISTORY REVIEW REVEALED THAT THE DEVICE WAS PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION. DURING PREVIOUS REPAIRS THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF DAMAGED BATTERY ALARM WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS IDENTIFIED AS DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THE REPORTED CONDTIION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY ALARM. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1