BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2202663 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18299
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.08.92. EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 804:26 ON CHANNEL C WAS CONFIRMED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE PROBLEM WAS NOT REPRODUCED. THE FAILURE CODE 804:26 OCCURRED ON ALL THREE CHANNELS AND THERE IS NOTHING ATTRIBUTABLE TO A HARDWARE DEFECT. THEREFORE, THE ROOT CAUSE WAS ASSIGNED TO A SOFTWARE FAILURE. THE DEVICE WAS TESTED PER BAXTER PROTOCOL. NO REPAIRS WERE REQUIRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE INFUSION PUMP FOR FAILURE CODE 804:26 ON CHANNEL C. THIS CONDITION HAS THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN. THERE IS NO FURTHER COMPLAINT INFORMATION 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