BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1852573 · Received October 4, 2010

    Report

    Report Number
    6000001-2010-03723
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY ISSUE WAS CONFIRMED BY BAXTER PERSONNEL AS A DEPLETED BATTERY ALARM. THIS CONDITION WAS CAUSED BY DEPLETED MAIN BATTERIES. THIS CONDITION WAS RESOLVED AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN BY REPLACING THE MAIN BATTERIES AND BATTERY HARNESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP HAD A BATTERY ISSUE. DURING REVIEW OF THE PUMP'S EVENT HISTORY, BAXTER PERSONNEL CONFIRMED THE REPORTED CONDITION AS A DEPLETED BATTERY ALARM AND DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.92.

    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