BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3862994 · Received June 4, 2014

    Report

    Report Number
    2016493-2014-00265
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION OF MORPHINE. THE PCA ORDER WAS 2.5 MG BOLUS EVERY 6 MINUTES. THE SYRINGE SIZE WAS 30 ML. THE INFUSION STARTED IN THE AFTERNOON ON (B)(6) 2014. THE SYRINGES WERE NOTED TO BE EMPTY AT 1836 AND 2203. THE PT REQUIRED NARCAN AND ADDITIONAL BLOOD DRAWS DUE TO RECEIVING TOO MUCH MORPHINE. THE PT IS CURRENTLY IN STABLE CONDITION. NO FURTHER PT OR EVENT INFO WAS PROVIDED. THE CUSTOMER REQUESTS AND EVENT LOG REVIEW FROM 1200 TO 2300 ON (B)(6) 2014 TO REVIEW THAT THE DEVICE WAS INFUSING AS PROGRAMMED AND HOW MUCH MORPHINE WAS INFUSED DURING THIS TIMEFRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326810 ALARIS PCA MODULE PCA INFUSION DEVICE FRN CAREFUSION CORP 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PC UNIT, SN (B)(4)| 30ML SYRINGE AND PCA ADMIN SET, MFR/MODEL/LOT UNK