BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1237929 · Received November 21, 2008

    Report

    Report Number
    6000001-2007-88271
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    April 6, 2007
    Report Date
    May 7, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY RISK MANAGER INDICATES THE FOLLOWING: MEDICATIONS INCLUDE: HETASTARCH 6% 500ML PRN, NITROGLYCERINE 3 MG/HR CONTINUOUS, NITROPRUSSIDE CONTINUOUS IV, METROPROLOL 1 MG Q 5 MIN PRN, ONDANSETRON 4 MG Q 6 HR PRN, PROCHLORAPERAZINE 25 MG Q 6 HR PRN, MORPHINE 2 MG Q 1HR PRN, PANTOPRAZOLE 40 MG DAILY, PROPOFOL 1% CONTINUOUS IV, PHENYLEPHRINE 1 MG OR IV, EPHEDRINE 50 MG OR IV, CEFUROXIME 1,500 MG IV, AMINOCAPROIC ACID 5 G OR IV, AND HEPARIN 10,000 UNITS PLASMALYTE OR IV. THE VITAL SIGNS PRIOR, DURING, AND AFTER THE EVENT INCLUDED A BLOOD PRESSURE OF 136/77, 82/58, AND 76/56 IN 2007. THE BLOOD PRESSURE THE NEXT DAY, WAS 134/81 AND RESPIRATIONS BETWEEN 10-12. INTERVENTIONS INCLUDED A BOLUS DOSE OF EPINEPHRINE (DOSE UNKNOWN). THE PATIENT OUTCOME INDICATES THE PATIENT WAS DISCHARGED IN STABLE CONDITION WITH NO DSYRHYTHMIAS NOTED. NO EVALUATION INCIDENT WAS PROVIDED BY THE FACILITY. THE DEVICE EVALUATION RESULTS WERE PROVIDED IN THE FOLLOW UP MEDWATCH SUBMITTED TWO MONTHS LATER. COLLEAGUE PUMP WAS EVALUATED TO IDENTIFY THE MALFUNCTION WHICH INITIATED THIS COMPLAINT. THE EVENT HISTORY WAS REVIEWED AND DID NOT CONTAIN ANY FAILURE CODES OR INDICATIONS THAT THE DEVICE STOPPED AND ALARMED DUE TO DEVICE MALFUNCTION. THE EVENT HISTORY WAS DOWNLOADED AND REVIEWED FOR THE REPORTED DATE. AS PER THE HISTORY, CHANNEL A AND B HAD TWO AIR DETECTED SET ALARMS AND TWO DOWNSTREAM OCCLUSION SET ALARMS. NO FAILURE WAS FOUND IN THE EVENT HISTORY AND PUMP PERFORMED AS DESIGNED. THE PUMP WAS FURTHER TESTED PER STANDARD FUNCTIONAL TESTS AND THE DEVICE PERFORMED WITHIN SPECIFICATIONS. THERE WERE NO MALFUNCTIONS OF THE PUMP. THERE ARE NO CORRECTIONS ASSIGNABLE TO THIS INCIDENT OR FAILURE RATE INFORMATION THAT CAN BE PROVIDED AND THERE IS NOTHING TO EVALUATE VERSUS THE DEVICE DESIGN CHANGES. NOT APPLICABLE, NO PRODUCT FAILURE. ADDITIONAL PATIENT INFORMATION PROVIDED ABOVE. EVALUATION RESULTS PROVIDED IN PREVIOUS FOLLOW UP MEDWATCH. BASED ON THE REVIEW OF THE EVENT HISTORY, THERE WAS NO MALFUNCTION OF THE PUMP ASSOCIATED WITH THE INCIDENT, THEREFORE, NO TRENDING INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF POWER FAILURE WAS NOT CONFIRMED AND COULD NOT BE DUPLICATED DURING SERVICE. THE PUMP WAS POWERED ON SELF TEST FOR AC AND BATTERY WITHOUT ANY FAILURES. THE PUMP PASSED THE DOWNSTREAM OCCLUSION TEST AND AIR IN LINE TEST ON ALL THREE CHANNELS. THE PUMP PASSED THE KEYPAD TEST. THE BATTERIES WERE 13 ALARMS BELOW THRESHOLD. THE BATTERIES WERE REPLACED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT DURING PATIENT INFUSION FOR OPEN HEART SURGERY, THE PUMP WAS INFUSING DOPAMINE ON ONE CHANNEL AND EPINEPHRINE IN THE OTHER CHANNEL. BOTH CHANNELS ALARMED AND INFUSION STOPPED. THE VITAL SIGNS WERE STABLE PRIOR TO THE EVENT. THE BLOOD PRESSURE REPORTEDLY DID DROP SLIGHTLY AFTER THE INFUSION STOPPED. ANOTHER PUMP WAS USED TO CONTINUE TO CONTINUE THE INFUSION OF THE DRUGS. THE VITAL SIGNS RETURNED NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening