BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2221664 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20539
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 20, 2011
    Report Date
    August 10, 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). 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 WILL NOT BE RETURNED TO BAXTER (B)(4) BECAUSE IT WAS SERVICED ON-SITE BY THE CUSTOMER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS INVOLVED A COLLEAGUE P1.7 INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 7.01.00. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT SERVICED BY BAXTER PRIOR TO THIS EVENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FINDING NO DEVIATIONS, NONCONFORMANCES, FAILURES, OR REWORK THAT OCCURRED DURING MANUFACTURING. THERE WERE NOT ANY RELEASE / TESTING SPECIFICATIONS THAT WERE NOT MET DURING FIRST PASS TESTING THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. THIS ISSUE HAS BEEN ESCALATED TO CORRECTIVE AND PREVENTATIVE ACTION (CAPA).

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO BAXTER (B)(4) A COLLEAGUE INFUSION PUMP WHERE "HAS NO MAINS LED LIT WHEN PLUGGED INTO MAINS SUPPLY. MAINS INLET FUSES HAVE BEEN FOUND TO BE FAULTY AND HAVE BEEN REPLACED BY THE CUSTOMER". IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. ACCORDING TO THE FACILITY REPRESENTATIVE, THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1