BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1831498 · Received September 10, 2010

    Report

    Report Number
    6000001-2010-03137
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 24, 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). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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 CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DEPLETED BATTERY ALARM WAS DISCOVERED AND CONFIRMED IN THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL. 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.

    Additional Manufacturer Narrative · 1

    (B)(4), A SERVICE HISTORY REVIEW DETERMINED THAT THIS DEVICE HAS NOT PREVIOUSLY BEEN SERVICED BY BAXTER. 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 MDQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING REVIEW OF THE PUMP'S EVENT HISTORY, BAXTER (B)(4) DISCOVERED A COLLEAGUE INFUSION PUMP HAD EXPERIENCED A DEPLETED BATTERY ALARM, WHICH INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.06.00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1