BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE

    MDR report key: 1982294 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00754
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    August 23, 2010
    Report Date
    October 29, 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 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. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE IS FAULTY MAIN BATTERIES. THE MAIN BATTERIES AND HARNESS HAVE BEEN REPLACED. ADDITIONAL: A TREND REVIEW HAS BEEN PERFORMED AND THERE HAVE BEEN SIMILAR REPORTS MADE TO BAXTER. THE ROOT CAUSE WILL CONTINUE TO BE INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4). THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.63.92, CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP THAT HAD DAMAGED AT THE REAR HOUSING. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING THE PRODUCT EVALUATION AT BAXTER, IT WAS DISCOVERED THAT A BATTERY DEPLETED SET ALARM OCCUR DURING INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1