BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PCA MODULE

    MDR report key: 2102032 · Received May 20, 2011

    Report

    Report Number
    2016493-2011-00342
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REQUEST FOR A LOG REVIEW FOR THE SUSPECTED FENTANYL DIVERSION WAS COMPLETED. THE SUSPECTED FENTANYL DIVERSION COULD NOT BE DEFINITIVELY CONFIRMED. THE INITIAL FENTANYL INFUSION STARTED ON (B)(4), 2011, AT 9:30 PM. THE PROGRAM RAN FOR APPROXIMATELY 1 HOUR BEFORE THE DOOR WAS OPENED AND SYRINGE CLAMP ALARMS ACTIVATED. THE SAME INFUSION PARAMETERS WERE ENTERED AGAIN. TAKING INTO ACCOUNT THE AMOUNT INFUSED AND THE NEW STARTING VOLUME, 7.6044 ML ARE UNACCOUNTED FOR. THE EVENT COULD HAVE OCCURRED DURING THE REPROGRAMMING OF THE INFUSION. THE DEVICE OR INFUSION SET WAS RETURNED, SO NO FURTHER INVESTIGATION WAS CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FENTANYL DIVERSION AND REQUESTED A REVIEW OF THE LOGS; THE TIME OF SUSPECTED DIVERSION IS (B)(6), 2011. ONE NURSE WAS FOUND IN A PT ROOM WITH THE FENTANYL SYRINGE AND TUBING OUT OF THE PUMP. SHE HAD THE KEY THAT WAS REMOVED FROM THE PYXIS UNIT. THE PT WAS NOT ONE OF HER PTS. IT WAS CONFIRMED BY THE DIRECTOR OF PHARMACY THAT THE PT WAS WITHOUT MEDICATION FOR ONLY FEW MINUTES. THERE WAS NO MEDICAL INTERVENTION OR NEGATIVE OUTCOME AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PCA MODULE MEA CAREFUSION CORP 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SERIAL NUMBER (B)(4)