BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2180394 · Received July 27, 2011

    Report

    Report Number
    6000001-2011-15055
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 20, 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). THE CUSTOMER'S REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH 550:320:666:0000 FAILURE WAS CONFIRMED DURING PRODUCE EVALUATION. THE CAUSE OF THIS CONDITION WAS DETERMINED TO BE A FAULTY USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB). THE UIM PCB WAS REPLACED TO FIX THE REPORTED CONDITION. THIS INVOLVED A COLLEAGUE INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 7:01:00. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(6) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A 550:320:666:0000 FAILURE CODE. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS A CASE, WHICH WAS REPORTED TO BAXTER (B)(6) ON (B)(6) 2011. THE COMPLAINT WAS RECEIVED FROM (B)(6) HOSPITAL AND REFERS TO AN INCIDENT INVOLVING COLLEAGUE SINGLE CHANNEL MONOCHROME PUMP ENGLISH V1.7 (2M81517K) ON SERIAL NUMBER (B)(4). THE REPORTER STATES ERROR LOG 550:320:666:0000. THIS HAS BEEN LOGGED FOR TRENDING PURPOSES ONLY. COLLECTION TO BE ARRANGED BY (B)(6). THERE WAS NO PATIENT INVOLVED. THE OCCURENCE DATE IS NOT SUPPLIED.

    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