BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 1934800 · Received December 16, 2010

    Report

    Report Number
    1934800
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT BENT A METAL FORK INTO A SPECIFIC SHAPE THAT ALLOWED HIM TO DISENGAGE THE PLUNGER MECHANISM ON AN ALARIS 8120 PCA MODULE. ONCE THE PLUNGER HEAD WAS RAISED ABOVE THE SYRINGE THE PATIENT PRESSED DOWN ON THE SYRINGE PLUNGER AND SELF-ADMINISTERED 13MG OF DILAUDID. PATIENT WAS FOUND UNCONSCIOUS AND IN RESPIRATORY ARREST WITH A O2 SAT LEVEL OF 40%. A REVERSING AGENT WAS ADMINISTERED. AFTER THE PATIENT RECOVERED HE ADMITTED WHAT HE HAD DONE, PRODUCED THE FORK AND DEMONSTRATED HOW HE WAS ABLE TO MANIPULATE THE PCA MODULE. A CLINICAL ENGINEERING TECHNICIAN WAS ABLE TO DUPLICATE THE EVENT. THE PCA MODULE AND THE FORK HAVE BEEN SEQUESTERED FOR FURTHER INVESTIGATION.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE DESIGN OF THE SYRINGE COVER ALLOWS THE INTRODUCTION OF VERY THIN OBJECTS INTO THE COMPARTMENT CONTAINING THE PCA SYRINGE. THERE IS A VERY SMALL CRACK BETWEEN THE TWO COVER HALVES (1 TO 2 MM) WHEN THE COVER IS LOCKED. A TOOL CAN BE USED TO TURN THE RELEASE KNOB AND DISENGAGE THE PLUNGER HEAD IF THE TOOL IS BENT IN A VERY SPECIFIC PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE PUMP, INFUSION, PCA MEA CAREFUSION 303, INC. 8120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention NO OTHER THERAPIES