BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1832909 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03189
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW OF THE EVENT HISTORY, THE OCCURRENCE DATE OF THIS EVENT WAS DETERMINED TO BE (B)(6) 2010. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 WAS CONFIRMED DURING PRODUCT EVALUATION. NO ASSIGNABLE CAUSE WAS PROVIDED DURING PRODUCT EVALUATION. THIS IS A BAXTER OWNED DEVICE AND WILL NOT BE REPAIRED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR WHICH CARE AREA THIS EVENT OCCURRED. THERE IS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. DURING REVIEW OF THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING DISCOVERED THIS EVENT INTERRUPTED DELIVERY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAD NO AC POWER OR BATT CHARGE LEDS LIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1