BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3170759 · Received May 22, 2013

    Report

    Report Number
    2016493-2013-00240
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 30, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NURSE REPORTED THAT LIPIDS WERE SET TO INFUSE AT 10 ML/HR FOR 25 HOURS. THE ENTIRE AMOUNT INFUSED IN 15 HOURS. NO PATIENT HARM. THE TUBING WAS DISCARDED. THE DEVICES WERE SENT TO BIOMED. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PATIENT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227321 ALARIS PCA MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE ADMIN SET: MODEL/LOT UNK