BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3131553 · Received May 16, 2013

    Report

    Report Number
    9616066-2013-00381
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    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). 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

    CUSTOMER REPORTED AIR-FLUID STRIPING WAS SEEN IN THE IV SET AND THE PUMP MODULE DID NOT ALARM FOR AIL. STATED D5 1/2 NS WITH 20 MEQ KC1 WAS INFUSING WHEN THE AIR IN THE LINE WAS NOTED; THE DRIP CHAMBER WAS 1/2 FULL. THE AIR-FLUID STRIPING WAS SEEN IN THE PUMP SEGMENT BELOW THE UPPER FITMENT DOWN TO APPROXIMATELY 4 INCHES FROM THE PT. NO AIR REACHED THE PT. REPORTED THE COLLAR ON THE MALE LUER ON THE PRIMARY SET WAS BROKEN; THE SET REMAINED ATTACHED TO THE PT WITHOUT ANY REPORT OF LEAKAGE. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218695 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)