MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	777702E
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual and functional evaluation of the sample, the reported issue was not confirmed; the sample passed testing accordingly.A root cause was not able to be determined at the time.The following sections were corrected or completed: section d1 brand name: kangaroo.Section d3 manufacturer name: cardinal health 200, inc.Section h4 device manufacture date: 30-aug-2022.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• 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
• Report Number: 1282497-2024-00500
• Device Sequence Number: 8509827
• Product Code: KNT
• UDI-Device Identifier: 10884521724129
• UDI-Public: 10884521724129
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male