BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD EXTENSION SET

    MDR report key: 6349768 · Received February 22, 2017

    Report

    Report Number
    9616066-2017-00293
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 30, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A CRACKED AND LEAKING FILTER ON AN EXTENSION SET WAS NEITHER CONFIRMED NOR REPLICATED. EACH OF THE CUSTOMER-PROVIDED TUBING SETS WAS FUNCTIONING EFFECTIVELY THROUGHOUT INVESTIGATIONAL TESTING. NO FLUID LEAKS OCCURRED AT ANY TIME, AND NO DAMAGE WAS OBSERVED ON THE FILTER. THE ROOT CAUSE OF A CRACKED AND LEAKING FILTER ON AN EXTENSION SET COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: NON-CFN EXTENSION SET; 2 SPIRO CONNECTORS; NON-CFN SPIKE ADAPTER; 1000ML BAXTER BAG (B)(4), LOT Y221507, EXP: JUL 18, 0.9% SODIUM CHLORIDE INJECTION; THERAPY DATE: (B)(6) 2017.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 CHEMOTHERAPY INFUSION EPOH WAS INFUSING AT A RATE OF 28 ML/HR. FOR 12 HRS. THE USER NOTED SPOTS OF ¿ORANGE¿ ON THE BEDSHEET AND FOUND A CRACK ON THE FILTER. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132427 MAXGUARD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MX9166

    Patients

    Seq Age Sex Outcome Treatment
    1 8015,2426-0007,10013072,8100,TD