BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 2012178 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01735
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF CONSTANT AIR ALARMS WAS CONFIRMED DURING REVIEW OF THE EVENT HISTORY LOG. THE ASSIGNABLE CAUSE WAS A DEFECTIVE AIR IN LINE (AIL) PRINTED CIRCUIT BOARD (PCB). THE AIL PCB WAS REPLACED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. THE USER INTERFACE SOFTWARE VERSION IS 5.09.90.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED A CONSTANT FALSE AIR IN LINE ALARM. IT IS UNKNOWN WHICH PROCESS STEP THE REPORTED CONDITION OCCURRED DURING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, AND THEREFORE, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THE SOFTWARE VERSION FOR THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1