BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 3043456 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00171
    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
    NOT APPLICABLE

    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. THE PUMP MODULE WAS ALARMING "OCCLUSION PT SIDE" AND THE LEAK WAS NOTICED AT THAT TIME. THE FILTER WAS REMOVED AND THE ALARM STOPPED. THE FILTER WAS IN USE FOR 4 DAYS AND WAS DUE TO BE CHANGED THAT DAY. THERE WERE MULTIPLE MEDICATIONS INFUSING THROUGH THE FILTER. MULTIPLE IV SETS ARE CONNECTED TO 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. 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
    106191 ALARIS EXTENSION SET FPA FPA CAREFUSION CORP. 10011865 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IV CATHETER: MFR/MODEL/LOT UNKNOWN| ICU MEDICAL IV CONNECTOR MC100: LOT UNKNOWN| ALARIS PC UNIT: SN UNKNOWN| TRIFURCATED EXTENSION SET: ACACIA BG-004-05| ALARIS PRIMARY SET: MODEL 2420-0007, LOT UNKNOWN| ALARIS PUMP MODULES: SN UNKNOWN