BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO EXTENSION SET

    MDR report key: 7830637 · Received August 29, 2018

    Report

    Report Number
    9616066-2018-01521
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Report Date
    August 9, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403240782
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 5ML ZR FLUSH SYRINGE OF 0.9% SODIUM CHLORIDE INJECTION USP (LOT 3133040, EXP 2020-04-01). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT THE SET LEAKED FROM AN UNKNOWN PORT WAS CONFIRMED TO BE A LEAK FROM TWO MAXZERO PORTS. FUNCTIONAL TESTING RESULTED IN NO LEAKING. PRESSURE TESTING SHOWED LEAKING FROM TWO OF THE MAXZERO COMPONENTS. CLOSER INSPECTION OF THE VALVES UNDER MAGNIFICATION SHOWED A MICROCHANNEL ON THE INTERIOR WALLS OF EACH VALVE, WHICH ALLOWED FLUID TO LEAK. THE SOURCE OF THE LEAK IS A MICROCHANNEL FOUND IN EACH MAXZERO VALVE WHICH CREATED A FLUID PATH. THE ROOT CAUSE OF THE MICROCHANNEL IS A MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PRODUCT LEAKED ON THE CARDIOVASCULAR UNIT WHEN THE PATIENT WAS BEING INFUSED WITH LIPIDS, TPN, AND PGE. IT IS UNKNOWN WHICH PORT LEAKED. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE PRODUCT LEAKED ON THE CARDIOVASCULAR UNIT WHEN THE PATIENT WAS BEING INFUSED WITH LIPIDS, TPN, AND PGE. IT IS UNKNOWN WHICH PORT LEAKED. THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PRODUCT LEAKED ON THE CARDIOVASCULAR UNIT WHEN THE PATIENT WAS BEING INFUSED WITH LIPIDS, TPN, AND PGE. IT IS UNKNOWN WHICH PORT LEAKED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670797 MAXZERO EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ9266 10885403240782

    Patients

    Seq Age Sex Outcome Treatment
    1 (3)8100,(3)PRI TUBING,8015, TD UNK