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

Model Number	385400
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Hypernatremia (2242)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The critical care director reported the bedside nurses are reporting the omni pumps are frequently stopping mid feeding and alarming.They said sometimes it is occurring every 5 minutes.Sometimes it corrects with repriming the tubing.Other times they reprime multiple times and then get a new feeding set.The med surg nurses today heard of similar issues with the pump beeping and stopping mid feeding.One patient who had a peg had to have the peg flushed out each time the pump paused.A report from a registered dietician that a patient who had scheduled water flushes had a high sodium the next day, and pump stoppage issues were suspected.Additional information received stated the concerns were brought up in a huddle group meeting after the events by the bedside nurses and dietician in the unit.The patient with the high sodium was transferred to the icu for hypernatremia (high sodium in the blood) from a med surgical unit.The patient had cardiac monitoring, free water flushes, and frequent labs.
Additional Manufacturer Narrative
The device history record could not be reviewed because the lot number was not available.The device was not returned for evaluation.If the pump is received, the investigation will be reopened.A root cause could not be determined.We will continue to monitor and take actions 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: 21968487
• Report Number: 1423537-2025-00190
• Device Sequence Number: 20958093
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: 10192253065701
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown