BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 2101987 · Received May 19, 2011

    Report

    Report Number
    2016493-2011-00343
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 25, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE SENT BACK PER THE CUSTOMER. UNABLE TO PERFORM A FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    MORPHINE WAS PROGRAMMED FOR PCA ONLY. IT WAS REPORTED THAT THE PT DID NOT GET ANY MEDICATION. NO PT HARM. HOSPITAL PERFORMED THEIR OWN INVESTIGATION AND DOES NOT WANT OUR ASSISTANCE IN ANY FURTHER INVESTIGATION. THEY DO NOT WANT TO SHARE ANY FURTHER INFO.

    Devices

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

    Patients

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