BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1862738 · Received October 8, 2010

    Report

    Report Number
    6000001-2010-03922
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION, AND THE BATTERIES AND HARNESS WERE PREVIOUSLY REPLACED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY DEPLETED ALARM WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN. BASED ON THE EVENT HISTORY REVIEW, THE BATTERY DEPLETED ALARM OCCURRED ON (B)(4) 2010 AS OPPOSED TO THE REPORTED OCCURRENCE DATE OF (B)(4) 2010. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A REVIEW OF THE EVENT HISTORY IT WAS DISCOVERED THAT THE BATTERY DEPLETED ALARM OCCURRED ON (B)(4) 2010. THE BATTERY DEPLETED SET ALARM OCCURRED ONCE ON CHANNEL A AND FIVE TIMES ON CHANNEL C.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH BATTERY DEPLETED ALARM. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN THIS EVENT OCCURRED. UPON REVIEWING THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING 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 VERSION OF 5.04.00.

    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