BEUDAMED
    FDA Adverse Event Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2120657 · Received June 10, 2011

    Report

    Report Number
    6000001-2011-07493
    Date Received
    June 10, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FALSE AIR IN LINE ALARM WAS DISCOVERED AND CONFIRMED BY A BAXTER SERVICE TECHNICIAN. THIS CONDITION WAS CAUSED BY THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD FAILURE. THE PUMPHEAD WAS REPLACED TO CORRECT THIS CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE CONDITION A COLLEAGUE INFUSION PUMP WITH AN AIR ALARM AND NO AIR IN TUBING WAS DISCOVERED BY BAXTER PERSONNEL. THIS EVENT WAS A FALSE AIR IN LINE ALARM. THIS OCCURRED IN PRODUCT ANALYSIS LAB DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS INVOLVED A REMEDIATED COLLEAGUE 2006 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1