BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOFLO VORTEX

    MDR report key: 21674522 · Received March 23, 2025

    Report

    Report Number
    1317056-2025-00080
    Event Type
    Death
    Date Received
    March 23, 2025
    Date of Event
    February 18, 2023
    Report Date
    April 18, 2025
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    15051684016827
    PMA / PMN Number
    K190559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT SEPSIS INFECTION CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT (SAE). NO PORT DEVICE WAS RETURNED FOR EVALUATION SINCE THERE WAS NO REPORT OF PORT DEVICE MALFUNCTION, DAMAGE OR PERFORMANCE ISSUE DURING USE. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE SHIP HISTORY REPORT (SHR) PACKAGING LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. STERILIZATION LOAD RELEASE RECORDS WERE REVIEWED FOR THE PACKAGING LOTS IN QUESTION; NO ISSUES WERE OBSERVED. LABELING REVIEW: THE DIRECTION FOR USE (DFU) PROVIDED WITH THE PORT DEVICE CONTAINS THE FOLLOWING STATEMENTS: CONTRAINDICATIONS: PRESENCE OF INFECTION, BACTEREMIA, OR SEPTICEMIA. WARNINGS: THE DEVICE IS TO BE IMPLANTED, USED, MAINTAINED AND REMOVED IN ACCORDANCE WITH CURRENT EVIDENCE-BASED GUIDANCE FOR INFECTION PREVENTION FROM AGENCIES/ORGANIZATIONS SUCH AS CENTERS OF DISEASE CONTROL (CDC) OR THE WORLD HEALTH ORGANIZATION. IT IS RECOMMENDED THAT INSTITUTIONAL POLICIES AND PROCEDURES ARE UPDATED PERIODICALLY TO REFLECT CURRENT EVIDENCE-BASED GUIDELINES FOR INFECTION PREVENTION. CONTAMINATION OF THE DEVICE MAY LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. PRECAUTIONS: CAREFULLY READ AND FOLLOW ALL INSTRUCTIONS PRIOR TO USE AFTER IMPLANTATION OR USAGE OF THE PORT, THE SYSTEM SHOULD BE FLUSHED TO CLEAR INFUSATES AND/OR BLOOD COMPONENTS IN ORDER TO MAINTAIN PATENCY. IF MORE THAN ONE DRUG IS TO BE ADMINISTERED, BETWEEN THE INDIVIDUAL DRUG APPLICATIONS, FLUSH THE SYSTEM WITH 5 TO 10 ML NORMAL SALINE FOR INJECTION TO PREVENT DRUG INTERACTION. POTENTIAL COMPLICATIONS: BACTEREMIA, CATHETER THROMBOSIS, DEATH, INFLAMMATION, INFECTION, THROMBOEMBOLISM, THROMBOPHLEBITIS, TUNNEL INFECTION, VASCULAR THROMBOSIS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT CONTINUES TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2023, DECEDENT G.W. UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT+ PRODUCT, DEVICE IDENTIFICATION NUMBER (B)(4), AND CATALOGUE NUMBER H787CT80LTBAVI0. THE DEVICE WAS IMPLANTED BY DR. MARSHALL L. DINES, M.D., AT ADVOCATE (B)(6, ILLINOIS, FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, DECEDENT G.W. PRESENTED HERSELF TO THE EMERGENCY DEPARTMENT OF ADVOCATE (B)(6) HOSPITAL ILLINOIS WITH A CHIEF COMPLAINT OF WEAKNESS, WHERE SHE WAS DIAGNOSED WITH SEPSIS. DECEDENT G.W. WAS PLACED IN THE ICU ON (B)(6) 2023 AND WAS PRONOUNCED DECEASED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769346 BIOFLO VORTEX PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC H787CT80LTBAVI0 15051684016827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| D| L| H