BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE

    MDR report key: 2073530 · Received May 2, 2011

    Report

    Report Number
    6000001-2011-03335
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    January 31, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 812:00 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. REVIEW OF THE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION OCCURRED ON (B)(6) 2011 NOT ON THE REPORTED OCCURRENCE DATE OF (B)(6) 2011. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 812:00, WHICH OCCURRED UPON DEVICE POWER-UP. 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 6.13.90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE PUMP, INFUSION FRN BAXTER HEALTHCARE - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1