BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE

    MDR report key: 2021839 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01942
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:03 WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO: 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 (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:03, WHICH OCCURRED UPON DEVICE POWER-UP. IT IS UNKNOWN WHERE THIS EVENT OCCURRED. UPON REVIEWING THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1