BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3121845 · Received May 15, 2013

    Report

    Report Number
    MW5030214
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    February 24, 2012
    Report Date
    May 15, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AT APPROXIMATELY 16:00, THE PATIENT CONTACTED THE RN BECAUSE HIS HYDROMORPHONE PCA PUMP WAS BEEPING WITH A MESSAGE OF "CHECKING SYRINGE." UPON INSPECTION, THE NURSE OBSERVED THAT THE SYRINGE WAS EMPTY, HAD A HOLE IN IT, AND THE PLUNGER WAS STILL SET TO APPROXIMATELY 15 ML REMAINING. THE PATIENT DENIED TAMPERING WITH THE DEVICE, AND WHEN THE RN LEFT THE ROOM TO DISCUSS THE INCIDENT WITH THE UNIT NURSE MANAGER AND SECURITY, THE PATIENT ELOPED. THE PATIENT HAD MANAGED TO OPEN THE ALARIS PCA PUMP WITHOUT A KEY AND CRACK OPEN THE SYRINGE, THEN CONSUMING THE MEDICATION ORALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214999 ALARIS PCA MODULE PCA SMART PUMP MEA CAREFUSION CORPORATION 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other