BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2210615 · Received August 12, 2011

    Report

    Report Number
    6000001-2011-18704
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS NEITHER CONFIRMED NOR REPRODUCED DURING SERVICE EVALUATION. THE ASSIGNABLE CAUSE WAS NOT IDENTIFIED AND NO REPAIRS WERE PERFORMED FOR THE REPORTED CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A COLLEAGUE INFUSION PUMP WITH A MANUAL TUBE RELEASE PROBLEM, WHICH COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED, HOWEVER IT OCCURRED IN THE GENERAL NURSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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