BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1759838 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01675
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF CHANNEL SELECT ON CHANNEL C PHM (PUMP HEAD MODULE) KEYPAD IS INOPERATIVE WAS FOUND DURING BAXTER DEVICE EVALUATION. FURTHER EVALUATION CONFIRMED AND DUPLICATED THIS CONDITION. THIS CONDITION WAS CAUSED BY AN INTERMITTENT STUCK KEY ON CHANNEL C PHM KEYPAD SELECT KEY. THE CHANNEL C PUMP HEAD MODULE KEYPAD WAS REPLACED TO CORRECT THE CONDITION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE WRITER INADVERTENTLY OMITTED THE SOFTWARE VERSION OF THE DEVICE IN THE FOLLOW-UP MEDWATCH REPORT 6000001-2010-01675 001. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.04.00, CATEGORIZED AS UNREMEDIATED. THE ACCURATE 510K NUMBER IS K044191.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED BY BAXTER. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION OR THE EVALUATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    CHILD HAS TYPE 1 DIABETES AND IS ON AN OMNIPOD INSULIN PUMP. CHILD HAD 2 SEIZURES IN ONE DAY AND WAS TRANSPORTED TO OUR FACILITY FROM ANOTHER ABOUT 4 HOURS AWAY. CAUSE OF SEIZURES TRACED TO HYPOGLYCEMIA. GLUCOMETER IN DEVICE READ A BLOOD GLUCOSE OF 164 MG/DL ACCORDING TO GRANDPARENTS WHO USED THE DEVICE. PARAMEDICS REPORTED A GLUCOSE OF 50 MG/DL. IN OUR FACILITY, THE GLUCOMETER IN THE DEVICE READ A CONSISTENT 40 MG/DL HIGHER THAN DID OUR GLUCOMETERS. DATES OF USE: (B)(6)2010 - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: TYPE 1 DIABETES MELLITUS. EVENT ABATED AFTER USE: YES.

    Description of Event or Problem · 1

    CHILD CAME IN FOR BLOOD TESTING ON FRIDAY 11/19. THE WARMER WAS PLACED ON CHILDS FINGER TO DO THE FINGER STICK. THE MOTHER SAID THE CHILDS FINGER STAYED PRETTY RED AND THE NEXT MORNING SHE HAD SEVERAL TINY BLISTERS WHERE THE WARMER BURNT THE CHILD. THE MOTHER STATED SHE HAS TAKEN PICTURES AND DOCUMENTED THE INCIDENT.

    Description of Event or Problem · 1

    DURING SERVICE AT BAXTER, A TECHNICIAN REPORTED THAT HAS A CHANNEL SELECT ON CHANNEL C PHM (PUMPHEAD MODULE) KEYPAD IS INOPERATIVE. THE REPORTED CONDITION WAS IDENTIFIED DURING PRODUCT EVALUATION. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN FOR THIS DEVICE.NO ADDITIONAL INFORMATION IS AVAILABLE.

    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