BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL

    MDR report key: 9700704 · Received February 12, 2020

    Report

    Report Number
    9615050-2020-00025
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 16, 2020
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005919
    PMA / PMN Number
    K151969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H10 - ONE USED LIST# 206680490, EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK. LOT# 3903806 AND ONE USED SPIROS¿ CLOSED MALE LUER, LIST # UNKNOWN, LOT# UNKNOWN WERE RECEIVED FOR EVALUATION. THE COMPLAINT OF LEAKAGE ON THE USED 206680490 EXTENSION SET W/MICRON FILTER SET COULD BE CONFIRMED. THE PRODUCT WAS TESTED PER PRODUCT SPECIFICATION. THERE WAS A LEAK FROM BOTH THE INLET AND OUTLET FILTERS. THE LEAKS APPEARED TO SEEP THROUGH FILTER VENT MATERIAL FROM VARIOUS LOCATIONS. THE PROBABLE CAUSE OF LEAKAGE IS DUE TO A TEMPORARY OR COMPLETE LOSS OF HYDROPHOBIC PROPERTIES OF THE FILTER VENT MATERIAL DUE TO AN INFUSATE REACTION DURING USE. FILTER VENT LEAKS ARE CURRENTLY UNDER FURTHER INVESTIGATION AT THE MANUFACTURING LOCATION. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 3903806 AND NO NONCONFORMANCE WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT INVOLVED AN EXTENSION SET 17 INCH, 0.2 MICRON FILTER CLAVE Y- SITE SECURE LOCK, THAT LEAKED DURING A 24 HOUR INFUSION OF ETOPOSIDE, DOXORUBICIN, AND CYTARABINE IN NORMAL SALINE. THE PATIENT REPORTED FEELING WETNESS AND A LEAK WAS NOTED AT THE AIR VENT OF THE 0.22 MICRON FILTER. IT WAS REPORTED THAT THE FILTER WAS NOT CRACKED. THE FILTER WAS REPLACED. THERE WAS PATIENT INVOLVEMENT AND NO HARM WAS REPORTED. THIS REPORT IS FOR TWO OF THREE EVENTS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164987 EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 2066828 3903806 10887787005919

    Patients

    Seq Age Sex Outcome Treatment
    1