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	Electrolyte Imbalance (2196)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported a concern was brought forward during a nurse practice council.Nursing staff have reported, although the pump indicates that flushes are being delivered, they are not seeing a corresponding decrease in the flush bag volume.If the nurse programs the pump for a feed with a 200 ml flush every four hours at the start of their shift, the flush bag is full at the end of the shift.The flush bag volume remains unchanged, even though the pump displays that approximately 600 ml of flushes have been administered.They believe the issue resulted in unanticipated electrolyte imbalance.There were no display or sound alarms during feedings.Patients required sodium correction.Additional information received stated they do not have any specifics because this was discussed at an rn council meeting; however, patients were requiring iv infusions and manual water flushes to correct their sodium levels.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A non-conformance/device history record review could not be conducted because a lot/serial number was not provided.Therefore, a review of the specific manufacturing and inspection records was not possible.However, all product lots are required to meet established acceptance criteria and must successfully pass defined visual and functional inspections prior to release.The device was not returned for evaluation; therefore, the affected device could not be evaluated, and a definitive root cause could not be determined.

• 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 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24521477
• Report Number: 1423537-2026-00055
• Device Sequence Number: 8430381
• 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): 03/25/2026

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?: Yes
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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