BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2389191 · Received December 27, 2011

    Report

    Report Number
    6000001-2011-42523
    Event Type
    Malfunction
    Date Received
    December 27, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS FOUND DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF AN UNSPECIFIED ?FAILURE? WAS CONFIRMED DURING EVENT HISTORY LOG REVIEW. HOWEVER, THE QUALITY ENGINEER COULD NOT DETERMINE THE ROOT CAUSE OF THIS CONDITION. THE PROBLEM WAS NOT REPRODUCED AND THE CAUSE WAS NOT IDENTIFIED. NO REPAIRS OR CORRECTIONS HAVE TAKEN PLACE AT THIS TIME. THIS ISSUE HAS BEEN ESCALATED TO CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH A "SYSTEM FAILURE WARNING ". THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, BUT OCCURRED IN THE "ICU". THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 6.13.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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