MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	385400
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Dehydration (1807)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's grandson reported the pump kept alarming "remove cassette" error.All troubleshooting was tried, including removing the cassette, using a new bag, cleaning the pump, and restarting.The problem was not resolved.This caused dehydration, and the patient was hospitalized due to lack of free water because the pump wasn't running.The patient needed multiple boluses to make up for the missed hydration because for about a week he wasn't getting water.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and no discrepancies were noted.The device was received for evaluation and upon powering on the device, no error codes were observed.The device was tested with water at feed rates of 800 ml/hr and 400 ml/hr for 30 minutes each, including both feed and flush cycles, without any issues.There were no alarms or error codes observed during the testing of the device.The reported issue could not be duplicated during testing; the device passed all tests and operated as intended.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23464138
• Report Number: 1423537-2025-00452
• Device Sequence Number: 21103361
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: 10192253065701
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 385400
• Device Catalogue Number: 385400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown