BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO EXTENSION SET

    MDR report key: 9079119 · Received September 17, 2019

    Report

    Report Number
    9616066-2019-02647
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 28, 2019
    Report Date
    August 28, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403240775
    PMA / PMN Number
    K140831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT THE MAXZERO DISCONNECTED FROM THE SYRINGE TUBING WAS NOT CONFIRMED BASED ON FUNCTIONAL AND PRESSURE TESTING PERFORMED. NO OBVIOUS DAMAGES OR ISSUES WERE OBSERVED WITH THE RECEIVED SET SAMPLES. THE SAMPLES WERE VISUALLY INSPECTED FOR DAMAGES TO THE COMPONENTS. INSPECTION OBSERVED NO OBVIOUS ISSUES. FUNCTIONAL TESTING WAS PERFORMED BY RE-PRIMING THE SYRINGE ADMINISTRATION SET. THE SYRINGE SET'S MALE LUER WAS THEN ATTACHED TO ONE OF THE TWO MAXZERO CONNECTORS OF THE BI-FUSE EXTENSION SET. NO DISCONNECTION OR ANY ISSUES WERE OBSERVED THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXZERO DISCONNECTED FROM THE SYRINGE TUBING WHILE THE CUSTOMER WAS PRIMING WITH SALINE. THE CUSTOMER CONNECTED THE SYRINGE TUBING TO THE BIFUSE AND IT LITERALLY TWISTS OFF THE SYRINGE TUBING. ANOTHER BIFUSE TUBING WAS OPENED AND THE SAME THING HAPPENED. CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 10ML BD SYRINGE, LOT: 9150587, EXP: 2022-05-31, 0.9% SODIUM CHLORIDE INJECTION. ALTHOUGH REQUESTED, PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXZERO DISCONNECTED FROM THE SYRINGE TUBING. CUSTOMER CONFIRMED NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871915 MAXZERO EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION MZ9265 18106354 10885403240775

    Patients

    Seq Age Sex Outcome Treatment
    1