BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3904927 · Received June 4, 2014

    Report

    Report Number
    2016493-2014-00255
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 06/04/2014. (B)(4). THE DEVICES 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

    CUSTOMER REPORTED THE DOSE REQUEST BUTTON ON THE PCA PENDANT STUCK DOWN AND THE PATIENT CONTINUED TO RECEIVE MEDICATION. CUSTOMER REPORTED DILAUDID 6MG/30ML IN A 60ML SYRINGE WAS PROGRAMMED TO DELIVER 0.5MG PER PCA DOSE, LOCKOUT 15 MINUTES WITH A MAX LIMIT 4 HOURS. IT IS UNKNOWN HOW MUCH MEDICATION WAS DELIVERED TO THE PATIENT. THE PATIENT REMAINED AWAKE, ALERT AND NOTIFIED THE NURSE OF THE ISSUE. NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328057 ALARIS PCA MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| ALARIS PCA MODULE SET: MODEL 30853, LOT UNK| 60ML SYRINGE: MANUFACTURER UNK, MODEL UNK, LOT UNK| MODEL 2426-0500, LOT UNK| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE ADMINISTRATION SET: