BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1981009 · Received February 8, 2011

    Report

    Report Number
    6000001-2011-00708
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN SERVICED TWO TIMES PRIOR TO THIS EVENT. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "OVERINFUSED." THE REPORTED CONDITION WAS NOT CONFIRMED OR DUPLICATED IN THE PRODUCT ANALYSIS LABORATORY (PAL). ALL ACCURACY TESTS PASSED WITHIN SPECIFICATIONS. THE ROOT CAUSE WAS DETERMINED TO BE MISPROGRAMMING- NON-SECONDARY SET-UP. THE LABELING REVIEW PERFORMED OF THE COLLEAGUE OPERATOR'S MANUAL DETERMINED THAT THE INSTRUCTIONS PROVIDED ARE SUFFICIENT IN INFORMING THE USER TO REVIEW THE PHYSICIAN'S ORDER AND LABELING ON THE SOURCE CONTAINER PRIOR TO STARTING AN INFUSION. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.04.00 CATEGORIZED AS UNREMEDIATED. THE PUMP WILL BE FORWARDED TO THE REPAIR SHOP. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE (BSR) COMMUNICATED THAT A CUSTOMER REPORT WAS RECEIVED INVOLVING A COLLEAGUE TRIPLE CHANNEL PUMP. THE FACILITY REPRESENTATIVE WAS CONTACTED AND STATED THAT A COLLEAGUE INFUSION PUMP OVERINFUSED ON (B)(6) 2011. THIS CONDITION WAS FOUND IN THE ONCOLOGY DEPARTMENT WHILE INFUSING A CHEMOTHERAPY DRUG. THE OVERINFUSION WAS FOUND BY THE FACILITY TO BE THE RESULT OF MISS-PROGRAMMING. THE FACILITY'S BIOMED DOWNLOADED THE EVENT HISTORY AND FOUND A SERIES OF BATTERY LOW ALERTS AND BATTERY DEPLETED ALARMS. WHEN THE DEVICE STOPPED INFUSING, THE DEVICE WAS REPROGRAMMED AT AN INCORRECT RATE. THE ORIGINAL RATES WERE: CHANNEL A: SALINE SOLUTION AT 100 ML/HOUR, CHANNEL B: DECADRON (FINISHED INFUSING BEFORE THE DEVICE WAS STOPPED), AND CHANNEL C: FLUOROURACIL AT 10.4 ML/24 HOURS. THE RE-PROGRAMMED RATES WERE: CHANNEL A: SALINE SOLUTION 10.4 ML/24 HOURS, CHANNEL B: NOT INFUSING, AND CHANNEL C: FLUOROURACIL AT 100 ML/HOUR. THE EVENT WAS DISCOVERED AT SHIFT CHANGE WHEN THE NURSE COMING ON CHECKED THE DEVICE FOR DELIVERY RATES. WHEN DISCOVERED, THE PATIENT WAS GIVEN A BOLUS OF SALINE SOLUTION AND WILL BE WATCHED AN ADDITIONAL THREE (3) OR FOUR (4) DAYS. CURRENTLY, THERE HAS BEEN NO PATIENT INJURY, BUT THE FACILITY IS STILL WATCHING THE PATIENT FOR SIGNS OF MUCOSITIS. THE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY NOT KNOWN.

    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 Hospitalization| R SALINE| DECADRON| FLUOROURACIL