BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QOUSTIC WOUND THERAPY SYSTEM

    MDR report key: 21026885 · Received December 26, 2024

    Report

    Report Number
    MW5163979
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    October 15, 2024
    Report Date
    December 31, 2024
    Manufacturer
    UNK
    Product Code
    NRB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO INVASIVE GROUP A STREPTOCOCCUS INFECTIONS IN A LONG-TERM CARE FACILITY ARE LINKED TO AROBELLA QOUSTIC WOUND THERAPY SYSTEM MODEL AR1000. THE CDC STREP LAB CONFIRMED THAT THE ISOLATES ARE IDENTICAL, WHICH DEMONSTRATES TRANSMISSION BETWEEN THE PATIENTS. THE SYSTEM IS USED BY A CONTRACTOR WOUND CARE SERVICE THAT HAS AN INAPPROPRIATE POLICY FOR REPROCESSING THE DEVICE AND ARE NOT ADHERING TO THE IFU (INSTRUCTIONS FOR USE). THE WOUND CARE SERVICE IS NOT USING SINGLE PATIENT USE TUBING OR IV SALINE BAG SOLUTION. THIS IS A WOUND DEBRIDEMENT DEVICE THAT CONTACTS OPEN WOUNDS THAT COULD BE COLONIZED WITH MULTIPLE ORGANISMS AND BLOOD BORNE PATHOGENS. THE IFU (INSTRUCTIONS FOR USE) INSTRUCTS USERS TO USE A LOW-LEVEL OR INTERMEDIATE LEVEL DISINFECTANT WIPE BETWEEN PATIENT USE, WHICH DOESN'T ADHERE TO THE SPAULDING CLASSIFICATION FOR DEVICE DISINFECTION AND STERILIZATION. THE WOUND CARE CONSULTANTS ARE IN CONTACT WITH THE MANUFACTURER OF THE DEVICE AND INSTEAD OF ADAPTING A POLICY THAT IS IN LINE WITH THE MANUFACTURER'S IFU (INSTRUCTIONS FOR USE), THE MANUFACTURE IS CHANGING THE IFU (INSTRUCTIONS FOR USE) TO MATCH THE CONSULTANT'S POLICY. THIS SITUATION HAS BEEN ESCALATED THROUGH ILLINOIS DEPARTMENT OF PUBLIC HEALTH AND THE CDC (CENTERS FOR DISEASE CONTROL) STREP OUTBREAK TEAM AND CDC (CENTERS FOR DISEASE CONTROL ) LTCF (LONG-TERM CARE FACILITY) TEAM. THE CDC STREP LAB TEAM ADVISED TO ENTER A MEDWATCH REPORT FOR THIS DEVICE. THIS DEVICE HAS BEEN USED THROUGH MULTIPLE LONG-TERM CARE FACILITIES AND COULD BE LINKED TO MULTIPLE OTHER GAS (GROUP A STREPTOCOCCUS) OUTBREAKS. TWO GROUP A STREP ISOLATES FROM 1 FACILITY ARE IDENTICAL, DEMONSTRATING TRANSMISSION. (B)(6).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION IS RECEIVED FOR A REPORT NUMBER MW5163979 ON 12/31/2024 TO MAKE THE MANUFACTURER UNKNOWN. AROBELLA MEDICAL, LLC., MINNETONKA, MN 55345 US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088913 QOUSTIC WOUND THERAPY SYSTEM WOUND CLEANER, ULTRASOUND NRB UNK MODEL AR1000/B/D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H