BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2103476 · Received May 26, 2011

    Report

    Report Number
    6000001-2011-04672
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. 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). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH AN AIR DETECTED SET WAS FOUND IN THE PUMP'S EVENT HISTORY BUT NOT DUPLICATED DURING PRODUCT EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED FOR THIS CONDITION AND NO REPAIR WAS NECESSARY. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4). A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND WITH A POSSIBLE FALSE AIR DETECTED ALARM, WHICH INTERRUPTED DELIVERY. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 8. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1