BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1932419 · Received December 17, 2010

    Report

    Report Number
    6000001-2010-05920
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    September 14, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IN ADDITION, CLARIFICATION HAS BEEN REQUESTED AS THE INFUSION REPORTED IS INCONSISTENT WITH THE PATIENT REACTION REPORTED. IF ADDITIONAL OR CLARIFIED INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS UNDETERMINED. THE DEVICE HISTORY REVIEW FOUND THAT THERE WAS NO EXCEPTION OBSERVED DURING MANUFACTURING. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INTERNATIONAL AFFILIATE HAS INDICATED THAT NO FURTHER FOLLOW-UP WITH THE CUSTOMER WILL BE PERFORMED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED ON (B)(6) 2010 DURING DRAIN CYCLE 2. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 490 ML AND THE DRAIN VOLUME WAS 1042 ML, WHICH MET IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE CUSTOMER REPORTED THROUGH THE HUMAN FACTORS ANALYSIS REPORT AN ISSUE WITH A COLLEAGUE VOLUMETRIC INFUSION PUMP (B)(4). A MORPHINE INFUSION RUNNING AT 2 MG/MINUTE (100 MG OF MORPHINE/ 100 CC BAG) WAS PROGRAMMED IN THE INTENSIVE CARE UNIT (ICU). DOSE, RATE AND VOLUME WERE DOUBLE CHECKED BY TWO NURSES AND THE INFUSION WAS STARTED AT 0530. AT 0700, A NURSE NOTED THERE WAS ONLY 20 CC OF VOLUME REMAINING, BUT THE PUMP READINGS INDICATED 90CC OF THE INFUSION REMAINED. THE PATIENT WAS DROWSY BUT STAFF WERE ABLE TO ROUSE HIM AND ASSESSED VITAL SIGNS WITHIN LOW LEVELS OF NORMAL. THE PHYSICIAN WAS NOTIFIED. STAFF REMOVED THE PUMP AND PLACED A NORMAL SALINE BAG ON THE PUMP AND PROGRAMMED IN THE SAME PARAMETERS AND THE PUMP RAN AT BOLUS LEVELS AGAIN. IT WAS REPORTED THAT THE BIOMEDICAL TECHNICIAN FOUND THAT CHANNEL B IS THE ONLY CHANNEL ON THE PUMP LOG WHERE A CONCENTRATION WAS CALCULATED EVEN THOUGH ?CHANNEL A? WAS REPORTED AS HAVING THE PROBLEM. VOLUMES WERE ACCURATE WHEN TESTED IN THE BIOMEDICAL ENGINEERING SHOP. THE BIOMED REPORT AND EVENT HISTORY REPORTS SHOWED NO PROBLEMS WITH THE PUMP AND SUGGESTS THAT NURSING INEXPERIENCE WITH THE 3 CHANNEL DEVICE MAY HAVE BEEN THE UNDERLYING ISSUE. THE CUSTOMER HAS REQUESTED BAXTER REINTRODUCE THE PUMP INTO THEIR ICU. THE PUMP WILL NOT BE RETURNED FOR EVALUATION. THE SOFTWARE VERSION FOR THIS PUMP IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention