BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2377310 · Received December 15, 2011

    Report

    Report Number
    6000001-2011-40936
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    October 27, 2011
    Report Date
    November 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE A DEFECTIVE PUMP HEAD MODULE (PHM). THE PHM WAS REPLACED TO FIX THE REPORTED CONDITION. ADDITIONAL INFORMATION: ACCORDING TO SERVICE HISTORY REVIEW, THE DEVICE IS NEW AND DOES NOT HAVE ANY PREVIOUS SERVICE HISTORY. 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. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW, THE QUALITY ENGINEER DETERMINED THE ROOT CAUSE OF THE DEFECTIVE POWER CORD WAS NOT IDENTIFIED. THERE WAS NO FAULT FOUND WITH THE PUMP MODEL UNIT (PMU) AND SERVICE DECIDED TO REPLACE THE PMU AS A PRECAUTIONARY MEASURE. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING ONE EXCEPTION DURING MANUFACTURING, HOWEVER, THE DEVICE WAS RE-TESTED AND FOUND TO BE PERFORMING AS DESIGNED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH THE REPORTED CONDITION OF 'FAILURE 808:02; INLET VALVE NOT OPEN POSITION 1 OCCURRED". IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS CONDITION HAS THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. 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 COLLEAGUE P1.7 (8.11.00).

    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