BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1791999 · Received August 10, 2010

    Report

    Report Number
    6000001-2010-02456
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH AN OUT OF SPEC BATTERY WAS CONFIRMED BY BAXTER QUALITY ENGINEERING AS A DEPLETED BATTERY ALARM. THIS CONDITION WAS CAUSED BY DEPLETED MAIN BATTERIES. DUE TO CUSTOMER DENIAL OF THE COST OF REPAIR ESTIMATE, NO REPAIRS WERE MADE TO THIS PUMP, AND IT WAS RETURNED UN-REPAIRED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH AN OUT OF SPEC BATTERY. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. UPON REVIEWING THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING CONFIRMED THIS CONDITION AS A DEPLETED BATTERY ALARM AND DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AND IT WAS RELATED TO HIS DIABETES. IT WAS STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT TIME OF DEATH. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1