BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2222109 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20559
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 12, 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 HAD AN EVALUATION ONSITE BY A FACILITY TECHNICIAN AND WILL NOT BE RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAULTY MAIN INLET FUSES WAS NOT CONFIRMED OR DUPLICATED BY BAXTER SERVICE PERSONNEL BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. QUALITY ENGINEERING HAS DETERMINED THE CAUSE OF THIS CONDITION TO BE BLOWN A/C FUSES (1.6 AMP SLOW-BLOW) THE CUSTOMER SELF-SERVICED THE DEVICE AND REPLACED THE 1.6 AMP SLOW-BLOW FUSES TO CORRECT THE CONDITION. THIS INVOLVED A COLLEAGUE VERSION 1.7 INFUSION PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 7.01.00. A DEVICE HISTORY REVIEW REVEALED NO ABNORMALITIES WERE FOUND. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE IS NEW AND DOES NOT HAVE A SERVICE HISTORY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH FAULTY MAIN INLET FUSES. IT IS UNKNOWN WHEN, OR IN WHICH CARE AREA, THIS EVENT OCCURRED. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    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