MAUDE Adverse Event Report: CARDINAL HEALTH CONFIRM NOW CO2 DETECTOR ENFIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 777702E

Device Problem Device Sensing Problem (2917)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/20/2024

Event Type  Injury  

Event Description

The customer reported that she helped a nurse with a patient in the critical care unit last night on 20feb2024.The item when working, should turn yellow when the co2 is present, but when they used the device, it failed to work causing the patient to have a major surgery (bronchoscopy) and is now on a ventilator.The customer said they relied on this item, and it failed.Additional information received from the initial reporter on 22feb2024 stated that the patient required an immediate bronchoscopy in the middle of the night.The patient had lost 300 ml of blood from his lung due to the event.As of 22feb2024 the patient remains on a ventilator with a chest tube that were placed because of the event, though he is now making some improvement.No medication was given related to the tube placement.The customer stated that the tube continued to be placed during the insertion procedure as the device seemed to indicate that the tube was not in the respiratory tract.Additional information received from the customer on 06mar2024 stated that a male nurse had attempted to pass the ng tube a couple of times and had difficulty, so she went to assist.She got to the 50cm or 55cm mark during insertion and it was getting harder to push so she stopped, then dark blood started to appear.She stated that she stopped several times during the insertion to check the co2 detector and each time the color was purple.It never turned yellow to indicate co2 or the tube being in the lung.After seeing the blood, they did not want to remove the tube because they did not know where it was.The patient had the bronchotomy that night to try to take the tube out.She said that she assumes the ng went into the right main bronchi but needs to check with radiology and the pulmonologist to confirm.She is also trying to find out why the patient bled so much and is wondering if there was something with the patient that prevented the device from reading co2.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: CONFIRM NOW CO2 DETECTOR ENFIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18940846
• MDR Text Key: 338132491
• Report Number: 1282497-2024-00500
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521724129
• UDI-Public: 10884521724129
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 777702E
• Device Catalogue Number: 777702E
• Device Lot Number: 222410051
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male