BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMARTSITE EXTENSION SET

    MDR report key: 9528328 · Received December 28, 2019

    Report

    Report Number
    9616066-2019-03762
    Event Type
    Malfunction
    Date Received
    December 28, 2019
    Date of Event
    December 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION OF THE SAMPLE CONFIRMED THE CUSTOMER'S REPORT THAT THE SMARTSITE WAS OVAL IN SHAPE; LEAKAGE WAS OBSERVED DURING A FLUSH THROUGH. A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE, THE CAUSE OF THIS ISSUE IS EXPOSURE OF THE SMARTSITE® TO AN EXTERNAL HEAT SOURCE THAT BRINGS THE COMPONENT TEMPERATURE ABOVE 60°C. A REVIEW OF THE MANUFACTURING PROCESS, BD STORAGE CONDITIONS, AND STERILIZATION PROCESS HAS NOT FOUND A POTENTIAL ROOT CAUSE FOR THIS LEVEL OF EXCESS HEAT.

    Description of Event or Problem · 0

    THE REPORTED FEEDBACK SUGGESTS THAT THERE WAS A LEAKAGE.

    Additional Manufacturer Narrative · 1

    20059E-00060/NO 510K THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 20059E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT.- K960280 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

    THE REPORTED FEEDBACK SUGGESTS THAT THERE WAS A LEAKAGE. THE IV FLUIDS (HARTMANN SOLUTION) WAS DISCONNECTED FROM THE 20059E-0006 EXTENSION SET, BLOOD BEGAN TO FLOW BACK FROM THE PATIENT AND LEAKED FROM THE PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323012 ALARIS SMARTSITE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 20059E-0006 17085853

    Patients

    Seq Age Sex Outcome Treatment
    1