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	05/07/2025
Type of Reportable Event	Death
Event or Problem Description
The vp of nursing reached out to a cardinal health sales rep to inform that a patient who had been on a kangaroo omni pump did not appear to be receiving the correct flushing volumes.The patient was started on (b)(6) 2025 for glucerna enteral feedings.The orders for pump delivery were to feed 40ml/hr and flush 200ml every 6h.The daughter said the pump was not flushing and the patient became dehydrated.The daughter said when she would change the bag every day she saw that the water was still in the bag but didn't call to ask why.The patient was admitted to icu on (b)(6) 2025 for dehydration.And passed away on (b)(6) 2025.Additional information received: the patient was admitted (b)(6) 2025, for enteral therapy with dysphagia related to cva and iv antibiotic therapy for positive blood cultures.Medical history documented at that time included hyperlipidemia, hypercholesterolemia, type ii diabetes mellitus, osteoporosis, degenerative lumbar spine disease, and suspected dementia.
Additional Manufacturer Narrative
The device was received may 27th, 2025.The device was received on software version 1.5.4612.Upon receipt, the device was disinfected using isopropanol alcohol.The device was subjected to a visual inspection to determine if any obvious damage or abnormalities could be detected.The device appeared to be normal with no damage or missing parts detected.Device intake, visual inspection, and certification was completed.The device had a sticker on the back indicating that it had undergone preventative maintenance and passed testing by (b)(4) on 3/20/2025.This is supported by the device stating that it had last passed certification 68 days ago (as of 5/27/2025).As part of end of line testing, a kangaroo omni pump must pass factory certification.The factory certification for this serial number passed on the first attempt on november 12th, 2024.After the device was received on may 27th, a service certification was run and passed.The device was powered on and the history function was engaged.The history feature records and stores in memory 30 days of delivery volumes.The history feature allows review in 1-hour increments for the last 72 hours and review of 30 days of history in 1-day increments.Review of this device indicated no history recorded until day 24.History data was present for days 24 through 30.The feed totalizer has a total fed of 5601ml and a total flushed of 9ml.This indicates that the pump fed at least 2,534ml that was captured outside of the history period.When the device was received, the keep settings button was pressed to record how the user programmed the device.The device was programmed in continuous mode with a rate of 40ml/hr using a standard feed/flush set.The flush settings were incomplete with only the flush volume of 40ml programmed and no flush interval programmed.Failure to program both the flush volume and flush interval will result in the device not performing the flush operation as the input was not fully programmed.Navigating to the show flush pages on either the ready to feed or feeding screens also show that the flush was not properly programmed.The kangaroo omni enteral feeding pump involved in complaint passed all testing and was determined to be functioning as expected.Analysis of the program settings, along with review of the history indicate incomplete programming of the flush settings by the user resulted in the pump not flushing.

• 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: 22152095
• Report Number: 1423537-2025-00226
• Device Sequence Number: 8468582
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: 10192253065701
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/05/2025
• 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: Death
• Patient Sex: Unknown