BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 2862706 · Received October 3, 2012

    Report

    Report Number
    2016493-2012-00434
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 19, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT THE PRODUCT WILL NOT BE RETURNED AND THAT THEY ALREADY KNOW WHAT CAUSED THE EVENT. AS A RESULT, THEY ARE RETRAINING THEIR NURSING STAFF AND REQUESTED PCA POCKET GUIDES AND HANG TAGS. PCA POCKET GUIDES AND HANG TANGS ARE BEING PROVIDED. BECAUSE THE DEVICE WERE NOT RETURNED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT OR DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A USER SELECTED AN INCORRECT CONCENTRATION WHEN PROGRAMMING THE PCA MODULE AND THE PT RECEIVED TOO MUCH MEDICATION. THE CUSTOMER DOES NOT REMEMBER THE MEDICATION NAME AND PROGRAMMING INFO. THERE WAS NO PT HARM REPORTED. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL/LOT #UNK| ALARIS PC UNIT, SN UNK| ALARIS PCA ADMINISTRATION SET