BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® EXTENSION SET

    MDR report key: 5910477 · Received August 29, 2016

    Report

    Report Number
    9616066-2016-01107
    Event Type
    Malfunction
    Date Received
    August 29, 2016
    Report Date
    August 4, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A LEAK WAS NOT CONFIRMED OR REPLICATED. VISUAL INSPECTION REVEALED NO DAMAGE ANYWHERE ON THE EXTENSION SET OR ANY OTHER COMPONENT. FUNCTIONAL TESTING FOUND NO ISSUES AND THIS WAS FURTHER CONFIRMED THROUGH LEAK TESTING AT PRESSURES UP TO 30 PSI. THE ROOT CAUSE OF THE REPORTED LEAK WAS NOT ABLE TO BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (2) 30910; NON-CFN STOPCOCK; NON-CFN MICROCLAVE; BD 60ML SYRINGE; THERAPY DATE UNKNOWN. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK NEAR THE FILTER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563498 ALARIS® EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10010570

    Patients

    Seq Age Sex Outcome Treatment
    1