BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 5999630 · Received October 5, 2016

    Report

    Report Number
    5999630
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    July 30, 2016
    Report Date
    August 17, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PCA PUMP CONTINOUS INFUSION WITH OPIOIDS IN 60CC MONOJECTS SYRINGE BY (B)(6), ALARMING OCCLUSION. PUMP CHANGED, TUBING CHANGED, AND MONOJECT SYRINGE PUMP CHANGED. PCA PUMP RESTARTED AND CONTINUED ALARMING OCCLUSION. SYRINGE REMOVED AND DREW BACK AIR THEN PRIMED SYRINGE TO TIP OF SYRINGE AND RELOADED, RESTARTED, AND PCA PUMP W/ OPIOID MEDICATION WITH INFUSE FOR 3-4 HOURS AND THEN ALARM OCCLUSION. HOSPITAL FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT INITIATED AN INVESTIGATION. THE ENTIRE INFUSION PUMP, SYRINGE AND PATIENT TUBING SET WAS TESTED FOR OCCLUSION ALARMS AND AFTER 3.5 HOURS, PCA PUMP STARTED TO ALARM "OCCLUSION." SEVERAL ATTEMPTS WERE MADE TO RESTART THE PCA PUMP, THE PUMP WOULD ALARM IN A SHORT PERIOD OF TIME. THE PCA PUMP WAS STOPPED, THE SYRINGE REMOVED AND THE TUBING REMOVED FROM THE SYRINGE. THE TUBING WAS TESTED FOR ANY FLOW OBSTRUCTIONS AND THERE WERE NONE. WHEN THE SYRINGE WAS TESTED WITHOUT THE PATIENT TUBING ATTACHED, IT WAS DIFFICULT TO PUSH THE PLUNGER TO THE POINT THAT IT WOULD REQUIRE EXCESSIVE FORCE TO DRIVE THE PLUNGER DOWN THE BARREL OF THE SYRINGE AND THE LEVEL OF FORCE WAS NEVER ACHIEVED. THE SYRINGE BY (B)(6) IS A MONOJECT 60CC. HOSPITAL TESTING CONFIRMED THERE IS AN ISSUE WITH THIS PARTICULAR SYRINGE. HOSPITAL FACILITY WAITING FOLLOW UP FROM (B)(6) TO DETERMINE FURTHER INVESTIGATION WITH SYRINGES DUE TO CONCERN THAT PATIENTS REQUIRING OPIOID MEDICATION ARE NOT RECEIVING THE APPROPRIATE AMOUNT OF MEDICATIONS AND THE RISK IF THE SYRINGE WERE TO BREAK LOOSE, RISK OF BOLUS GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652378 ALARIS PCA MODULE PUMP, INFUSION FRN CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR