BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2211346 · Received August 15, 2011

    Report

    Report Number
    6000001-2011-18867
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    March 14, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION, QUALITY ENGINEERING DETERMINED THE ROOT CAUSE THE OF THE REPORTED PROBLEM TO BE A DEFECTIVE SHUTTLE MOTOR. A LABELING REVIEW WAS COMPLETED AND IT WAS DETEREMINED THAT USER ERROR WAS NOT SUSPECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY. THE REPORTED CONDITION OF 812:04 WAS CONFIRMED DURING PRODUCT EVALUATION; HOWEVER THE ROOT CAUSE WAS NOT IDENTIFIED. THE PUMP HEAD MODULE WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH AN "812:40" FAILURE CODE. UPON REVIEW OF THE EVENT HISTORY LOG BY A BAXTER TECHNICIAN, IT WAS FOUND TO HAVE INTERRUPTED DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED RELATED TO THE DEVICE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.92. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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