BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2141861 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-09021
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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

    (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 843:320 WAS DETERMINED TO BE THE CONDITION OF FAILURE CODE 543:320:654:0000 DISCOVERED AND CONFIRMED BY BAXTER PERSONNEL IN THE PUMP'S EVENT HISTORY. THIS CONDITION WAS CAUSED BY A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD. THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS REPLACED TO CORRECT THIS CONDITION.. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 843:320. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS PROBLEM WAS IDENTIFIED DURING POWER-UP IN BIOMED SERVICES DEPARTMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.09.90 WHICH IS CATEGORIZED AS A COLLEAGUE 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1