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

Model Number	385400
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Dehydration (1807)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported one of their resident's son was with the patient in the room and observed that the water level in the flush bag did not appear to have decreased at all.He marked the level on the bag and noted that it did not decrease significantly over 48hrs.He alerted staff and when they looked at the pump history, it appeared no flushes had occurred over several days.The patient was admitted to the hospital and was found to be extremely dehydrated.She received iv fluids and was started on norepinephrine.The patient was transferred to the icu and a central line was placed.The patient was extremely confused and moaning, but not talking.She had a diarrheal bowel movement and also vomited.They discovered that the resident's feeding pump did not flush as prescribed/set in the pump, and the patient had not received the proper flush amount for 10 days.The customer took the pump and cleared the settings and the "clear total volumes" then reset the pump with the feeding orders and the same feeding set that the resident had been using.The pump was set to flush 50ml every hour but no flushes occurred during the more than 3 hours it was running.
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 indicated the product was released accomplishing all quality standards.The unit was received for evaluation and tested for the reported condition.The device logs indicate that after a dead battery event on (b)(6) 2025, the flush interval was cleared by the user, and subsequently, on (b) (6)2026, the flush volume was also removed.During these periods the pump did not flush because one or both required flush parameters were unset.When the flush was later reconfigured, the device performed as intended.Bench testing with the complaint configuration for 46 hours produced no alarms or missed flushes.The omni pump is functioning as designed.The reported complaint is potentially attributable to use related programming.We will continue to monitor and take action as applicable.

• 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: 24070968
• Report Number: 1423537-2026-00012
• Device Sequence Number: 9113367
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: 10192253065701
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2025
• 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: Female