BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1519755 · Received November 3, 2009

    Report

    Report Number
    6000001-2009-01116
    Event Type
    Malfunction
    Date Received
    November 3, 2009
    Date of Event
    October 20, 2009
    Report Date
    October 20, 2009
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) THIS PUMP UTILIZES USER INTERFACE MODULE MASTER SOFTWARE (B) (4), CATEGORIZED AS REMEDIATED. THE PUMP HAS BEEN RECEIVED AND EVALUATED BY BAXTER. THE REPORTED CONDITION WAS CONFIRMED AND DUPLICATED. THE ASSIGNABLE CAUSE IS THAT THE CHANNEL A PUMPHEAD MODULE KEYPAD IS INOPERATIVE DUE TO DAMAGED TRACES FOUND ON THE KEYPAD FLEX CABLE. UPON COMPLETION OF BAXTER'S INVESTIGATION OF THIS REPORT, THE PUMP WILL BE ROUTED TO OUR SERVICE DEPARTMENT FOR THE APPROPRIATE SERVICING TO BE COMPLETED PRIOR TO BEING RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B) (4). THERE IS A CAPA INVESTIGATION ASSOCIATED WITH THIS REPORT. (B) (4). THE PUMP IS AVAILABLE AND WILL BE SENT BACK TO BAXTER FOR AN EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER PERFORMED A LOT TO LOT COMPARISON FOR CKMB AFTER NOTING A SHIFT IN THE QC RESULTS WHEN SWITCHING FROM REAGENT TO LOT NUMBER 153686 TO REAGENT LOT NUMBER 155150. THE PT SERUM SAMPLES HAD BEEN PREVIOUSLY TESTED AND THE ORIGINAL RESULTS FOR THE PT SAMPLES HAD BEEN REPORTED. THESE RESULTS WERE NOT PROVIDED. THE RESULTS OBTAINED WHEN TESTED FOR THE COMPARISON WERE NOT REPORTED. ALL RESULTS ARE IN NG PER ML. SAMPLE 1 RESULT WITH LOT NUMBER 153686 WAS 6.58, RESULTS WITH LOT NUMBER 155150 WERE 4.98 AND 5.77. SAMPLE 2 RESULT WITH LOT NUMBER 153686 WAS 3.17, RESULTS WITH LOT NUMBER 155150 WERE 2.14 AND 2.35. SAMPLE 3 RESULT WITH LOT NUMBER 153686 WAS 3.77, RESULTS WITH LOT NUMBER 155150 WERE 2.32 AND 2.70. THE USER REFUSED A SERVICE VISIT AS THEY FELT THERE WAS NO ISSUE WITH THE ANALYZER PERFORMANCE.

    Description of Event or Problem · 1

    THE FACILITY INITIALLY REPORTED THAT THE PUMP WILL NOT STOP INFUSING, CONSTANT FLOW VERIFIED WITH AN INTERMITTENT STOP BUTTON. THIS WAS INITIALLY REPORTED TO HAVE OCCURRED DURING BIOMEDICAL TESTING. DURING A FOLLOW UP CALL TO THE FACILITY, THIS INCIDENT WAS FOUND TO HAVE OCCURRED DURING A VOLUNTARY REMOVAL OF THE SET FROM AN UNSPECIFIED PATIENT TO GIVE THE PATIENT MOBILITY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1