BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2196232 · Received August 9, 2011

    Report

    Report Number
    6000001-2011-17331
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE, BUT THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. A 510 NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510 NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH 754:00 FAILURE WAS CONFIRMED DURING PRODUCT EVALUATION. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE A FAULTY PUMP MODULE UNIT (PMU) AND THE SIGNAL HARNESS. THE PMU WAS REPLACED TO FIX THE REPORTED CONDITION. THIS INVOLVED A COLLEAGUE INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 7.01.00.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A FAILURE CODE 754:00; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE SOFTWARE VERSION IS CURRENTLY UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1