BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS EXTENSION SET

    MDR report key: 3983161 · Received June 27, 2014

    Report

    Report Number
    9616066-2014-00626
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 5, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K083472
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE AFFECTED PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED ANECDOTAL INFO REGARDING DISCONNECTIONS FROM THE MAXPLUS VALVE. A DISCONNECTION HAS OCCURRED PRIOR TO CONNECTION TO THE PT'S VENOUS ACCESS AND AFTER THE TUBING HAS BEEN PRIMED USING A MEDIFIL PRE FILLED SALINE SYRINGE. THE SYRINGE WILL DISCONNECT FROM THE IV TUBING WHILE THE IV LINE IS BEING ESTABLISHED. ALSO, MEDIFIL SYRINGE DISCONNECTIONS HAVE OCCURRED WHILE MEDICATIONS ARE BEING PUSHED WHICH CAUSED A LEAK OF THE SOLUTION. NO PT HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377783 MAXPLUS EXTENSION SET IV EXTENSION SET FPA CAREFUSION CORP. MPX5304-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HOSPIRA EXTENSION SET, MODELS/LOTS UNKNOWN| MEDIFIL SALINE SYRINGE