BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3983178 · Received June 27, 2014

    Report

    Report Number
    2016493-2014-00310
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HAVE BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SEVERAL HYDROMORPHONE PCA DEMANDS WERE PRESSED DURING THE NIGHT, BUT NO MEDICATION DELIVERY OCCURRED. INTENDED PROGRAMMING WAS HYDROMORPHONE PCA 0.5MG, CONTINUOUS 0.2MG/HR, 1 HOUR MAX OF 0.7MG, LOCKOUT OF 60 MINUTES. AT 0800, THE PUMP READ 1 DEMAND AND 0 DELIVERIES WHEN THE NURSE WENT TO CLEAR THE TOTALS. THE NURSE CHANGED THE PUMP AT 0940 AND VERIFIED THE SETTINGS WITH A SECOND RN. AT 1200, THE PUMP READ 1 DEMAND AND 1 DELIVERY. CUSTOMER IS REQUESTING AN EVENT LOG REVIEW. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377308 ALARIS PCA MODULE PCA INFUSION DEVICE FRN CAREFUSION CORP. 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EXTENSION SET, MFR/MODEL/LOT UNKNOWN| ALARIS PC UNIT, SN# (B)(4)| SYRINGE, MFR/MODEL/LOT UNKNOWN