BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD EXTENSION SET

    MDR report key: 2082820 · Received April 29, 2011

    Report

    Report Number
    3005748548-2011-00007
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 5, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF TUBING DISCONNECTED FROM THE END OF THE 0.2 MICRON FILTER WAS CONFIRMED HOWEVER THE REPORT OF LEAK AT FILTER WAS NOT CONFIRMED. ON THE RETURNED UNIT, THE TUBING HAD SEPARATED FROM THE FILTER. INSPECTION UNDER MAGNIFICATION REVEALED EVIDENCE OF SOLVENT IN THE JOINT; THERE WAS NO EVIDENCE OF DAMAGE OR DEFORMATION, AND THERE WAS NO OBVIOUS CAUSE FOR THE SEPARATION. IT IS POSSIBLE THAT AN INSUFFICIENT AMOUNT OF SOLVENT WAS APPLIED MAKING THE CONNECTION SUSCEPTIBLE TO SEPARATION IF SUFFICIENT FORCE WAS APPLIED. THE USER ALSO REPORTED THAT THE FILTER MIGHT BE LEAKING. THE FILTER WAS TESTED AND SHOWED NO EVIDENCE OF LEAKAGE. THE ROOT CAUSE OF THE TUBING DISCONNECTION AT THE 0.2 MICRON FILTER IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TUBING DISCONNECTED FROM THE END OF THE 0.2 MICRON FILTER DURING AN INFUSION OF TPN. THE FILTER SEEMS TO BE LEAKING AS WELL. NO PT HARM REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXGUARD EXTENSION SET FPA CAREFUSION CORPORATION MX9166 11187332

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK