BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2082239 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03800
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    600001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE WAS A FAULTY AIR IN LINE PRINTED CIRCUIT BOARD. THE AIR IN LINE PRINTED CIRCUIT BOARD HAS BEEN REPLACED. ADDITIONAL: THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, CATEGORIZED AS REMEDIATED. A SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND THE DEVICE WAS NOT PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. A TREND REVIEW HAS BEEN PERFORMED AND THERE WERE SIMILAR REPORTS MADE TO BAXTER. THE ROOT CAUSE WILL CONTINUE TO BE INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE OF 810:11. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED, HOWEVER, IT IS KNOWN TO HAVE OCCURRED IN THE EMERGENCY ROOM. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION REPORTED RELATED TO THE DEVICE. DURING THE PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT FAILURE CODE 810:11 OCCURRED DURING INFUSION, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN.

    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