BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2935368 · Received January 23, 2013

    Report

    Report Number
    9616066-2013-00048
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    October 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    RECEIVED A COPY OF A MEDSUN REPORT SUBMITTED BY THE CUSTOMER. THE IV TUBING CONNECTED TO AN EPIDURAL CATHETER HAD A CRACKED HUB AND WAS LEAKING. CUSTOMER MEDWATCH REPORT NOTED THE EPIDURAL CATHETER WAS LEAKING. AFTER SPEAKING WITH THE CUSTOMER, IT WAS IDENTIFIED IT WAS THE IV TUBING THAT WAS LEAKING. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFORMATION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33331 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2200-0500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR ALARIS PUMP MODULE, S/N UNKNOWN| EPIDURAL CATHETER, MFR/MODEL UNK| ALARIS PC UNIT, S/T UNKNOWN