BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE-P1.7

    MDR report key: 2191539 · Received August 4, 2011

    Report

    Report Number
    6000001-2011-16566
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A 12:222 ALARM WAS NOT CONFIRMED BY BAXTER PERSONNEL DURING PRODUCT EVALUATION. THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THE PUMP WAS RETURNED UNREPAIRED FOR THE REPORTED CONDITION. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.04.00 WHICH IS CATEGORIZED AS UNREMEDIATED. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING NO EXCEPTION, NONCONFORMANCE, OR REWORK THAT OCCURRED DURING THE MANUFACTURING OF THE COMPLAINT LOT OR SERIAL NUMBER.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH "12:222 ALARM." THIS EVENT OCCURRED UPON POWER UP BUT IT IS UNKNOWN IN WHICH CARE AREA THIS EVENT OCCURRED. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO REPORT OF 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 PRE-P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1