BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1233187 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-02776
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 3, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONDITION OF FAIL CODE 570 WAS CONFIRMED. THIS FAIL CODE WAS CAUSED BY DEPLETED BATTERIES. THE BATTERIES WERE 83 DISCHARGES BELOW ALARM THRESHOLD AND HAD 15 CHARGE/DISCHARGE CYCLES. THE MAIN BATTERIES WERE BATTERIES REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED FAILURE CODE 570. THE EVENT OCCURRED DURING BIO-MED TESTING. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1