BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYRINGE MODULE ADMINISTRATION SET

    MDR report key: 1101472 · Received August 6, 2008

    Report

    Report Number
    9616066-2008-00025
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO REQUESTED, AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    REPORTED INTERMITTENT BACK CHECK VALVE FAILURES FOR ABOUT THREE MONTHS PERIOD IN 2008. THIS INFO WAS SHARED DURING A CONFERENCE CALL WITH THE CUSTOMER RELATED TO ANOTHER INVESTIGATION REPORT. THE CUSTOMER USES THIS SET TO DELIVER TPN SOLUTION TO BABIES. SOME INCIDENTS CAUSED A DROP IN BLOOD SUGAR REQUIRING TREATMENT WITH CONCENTRATED DEXTROSE SOLUTION, HOWEVER, THE CUSTOMER DOES NOT HAVE THE SPECIFIC DETAILS SURROUNDING THESE REPORTED FAILURES. ALL SETS INVOLVED WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYRINGE MODULE ADMINISTRATION SET FPA, ADMINISTRATION SET FPA CARDINAL HEALTH ALARIS PRODUCTS 10798696 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention