BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 3043454 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00170
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY FOUND FLUID LEAKING THROUGH THE FILTER AIR VENT HOLE. THERE WERE MULTIPLE MEDICATIONS INFUSING THROUGH THE FILTER. MULTIPLE IV SETS ARE CONNECTED TO THE TRI-PORT EXTENSION SETS, WHICH ARE ATTACHED TO THE FILTER EXTENSION SET, CONNECTED TO THE IV CONNECTOR, AND THAT IS CONNECTED TO A PT IV CATHETER. THE FILTER WAS USED FOR 2 DAYS WHEN THE LEAK WAS NOTICED. THERE WAS NO PT HARM OR MEDICAL INTERVENTION REPORTED. NO ADD'L EVENT OR PT INFO WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106274 ALARIS EXTENSION SET FPA CAREFUSION CORP. 10011865 12105651

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IV CATHETER, MFR/MODEL/LOT UNKNOWN| LOT UNKNOW| ICU MEDICAL IV CONNECTOR MC100, LOT UNKNOWN| TRIFURCATED EXTENSION SET, ACACIA BG-004-05,| MEDFUSION SYRINGE PUMP, MODEL/SN UNKNOWN| ICU MEDICAL B2141 SYRINGE TUBING, LOT UNKNOWN