BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1004508 · Received February 28, 2008

    Report

    Report Number
    6000001-2008-00097
    Event Type
    Death
    Date Received
    February 28, 2008
    Date of Event
    December 20, 2007
    Report Date
    February 6, 2008
    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

    THE DEVICE WAS RETURNED TO THE FACILITY BIOMEDICAL DEPARTMENT ON AN UNKNOWN DATE AND REPAIRED ON AN UNKNOWN DATE. THE BIOMEDICAL TECHNICIAN REPORTED AT THAT TIME THAT "RIBBON CABLE ISSUE" OCCURRED AND WAS REPAIRED. THE DEVICE WAS PUT BACK INTO SERVICE. IN 2007, THE DEVICE WAS RETURNED TO THE BIOMEDICAL REPRESENTATIVE AT THE HOSPITAL. THE DEVICE WAS SENT ON TO THE HOSPITAL SERVICE, AND THEN SENT ON TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. THE EVENT HISTORY WAS NOT DOWNLOADED AT THE TIME OF THE EVENT NOR ON THAT DAY. THE DEVICE IS LOANER, NON-UPGRADED PUMP. PRODUCT ANALYSIS LAB SUMMARY: THE DEVICE PASSED THE POWER ON SELF-TEST. THE BATTERY SHOWS ZERO CHARGE/DISCHARGE CYCLES AND ZERO DISCHARGES BELOW ALARM THRESHOLD. FAILURE CODE 807:02 WAS NOTED ON CHANNEL B. THIS IS A GROSS POSITION SENSOR ERROR. INTERNAL INSPECTION OF THE PUMP SHOWED NO VISUAL DAMAGE. A BATTERY LOW ALERT OCCURRED 2 HOURS AND 23 SECONDS AFTER THE START KEY WAS PRESSED AND THE BATTERY DEPLETED ALARM OCCURRED 1 HOUR AND 41 MINUTES LATER. THE BATTERY DEPLETED ALARMS STOPS ALL THREE CHANNELS FROM INFUSING. CHANNEL A ENCOUNTERED A FAILURE CODE 16: 310: 903: 0002 DUE TO DEPLETED BATTERIES. THE PUMP PASSED THE KEYPAD TEST. PUMP HEAD MODULE CHANNEL B GROSS POSITION SENSOR VALUES WERE FOUND TO BE WITHIN SPECIFICATION. WHEN THE CHANNEL WAS OPENED USING THE MANUAL TUBE RELEASE SCARPING WAS NOTED. THE SHUTTLE MOTOR WAS REMOVED AND EXCESSIVE GREASE WAS NOTICED INSIDE AND OUTSIDE THE GEARBOX. THE MOTOR SCREWS DID NOT HAVE LOCTITE ON THEM. THE PRESSURE SENSOR CONNECTOR HAD FLUID INTRUSION ON PIN 7. THE REPORTED CONDITION WAS NOT CONFIRMED BUT WAS DUPLICATED DURING SERVICE. FAILURE CODE 16 WAS DUE TO DEPLETED BATTERIES.

    Description of Event or Problem · 1

    CALL WAS RECEIVED FROM A HOSPITAL SERVICE INDICATING A COLLEAGUE TRIPLE CHANNEL PUMP RECEIVED FROM THE HOSPITAL FAILED ALL 3 CHANNELS DURING A PATIENT INFUSION OF LEVOPHED, VASOPRESSIN AND A 3RD MEDICATION. THE PATIENT'S BLOOD PRESSURE DROPPED AND INTERVENTIONS WERE USED TO RESTORE THE BLOOD PRESSURE. THE BAXTER SALES REPRESENTATIVE RECOMMENDED BAXTER BE CONTACT AND TO SEND IN THE PUMP FOR EVALUATION. PER THE RISK MANAGER: THIS PATIENT WAS ADMITTED IN 2007 FOR "CARDIAC ISSUES". A WEEK LATER, THE PATIENT WAS INFUSING LEVOPHED, VASOPRESSIN AND A 3RD MEDICATION (CONCENTRATION, DOSE, RATE AND VOLUME UNKNOWN) VIA A COLLEAGUE TRIPLE CHANNEL PUMP WHEN ALL THREE CHANNELS FAILED, ALL 3 TUBING "GOT STUCK IN THE PUMP HEAD", AND FAILURE CODE 16 WAS NOTED. THE PATIENT'S BLOOD PRESSURE DROPPED TO AN UNKNOWN LEVEL. THE PATIENT WAS EXPERIENCING BLEEDING FROM AN UNKNOWN SOURCE AND DUE TO AN UNKNOWN REASON. THE NURSE REPLACED THE PUMP AND RESUMED THE INFUSIONS. IT IS UNKNOWN IF ANY OTHER INTERVENTIONS WERE REQUIRED OR ADMINISTERED. THE RISK MANAGER DECLINED TO PROVIDE ADDITIONAL CLINICAL INFORMATION. THE PATIENT REPORTEDLY EXPIRED ON AN UNKNOWN DATE. IT IS NOT KNOWN IF AN AUTOPSY WAS COMPLETED. CAUSE OF DEATH IS UNKNOWN. AN ON-SITE VISIT WAS OFFERED BUT HAS NOT BEEN ACCEPTED.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death