BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1832364 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03113
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 13, 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
    OTHER

    Narratives

    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. PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS EVALUATED AT THE CUSTOMER'S FACILITY BY A BAXTER FIELD TECHNICIAN. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION DISCOVERED AND CONFIRMED THE REPORTED CONDITION OF A BATTERY DEPLETED ALARM. THE ROOT CAUSE WAS DETERMINED BE DEPLETED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO REPAIR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A BATTERY DEPLETED ALARM WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MASTOID SURGICAL PROCEDURE THAT THE BUR WAS DULL. IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ANOTHER BUR WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.06.00, WHICH IS CLASSIFIED AS UNREMEDIATED.

    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