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

Model Number	385400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hyponatremia (4494)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the device was infusing water instead of tube feeding.There was a patient event of low sodium due to the inaccurate free water administered.Additional information received on 11jul2025 stated that the serial number of the pump used is unknown.The product number and lot number of the feeding set is unknown.Feed rate/volume settings are unknown.Flush rate/volume settings are unknown.Amount of feed delivered is unknown.Amount of flush delivered is unknown.It is not known if the pump history logged this as feed or flush.The patient was transferred from a medical surgical unit (lower level of care) to the intensive care unit (higher level of care).Once in the intensive care unit the patient received hypertonic saline (3% saline) to correct sodium levels and received seizure precaution monitoring.The patient was discharged and is alive.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device serial number was not available; therefore, a device history record and service history review could not be performed.Several pumps were returned for evaluation and no issues relating to the reported issue was observed.Based on additional information provided by the customer, the root cause is user error associated with not following the instructions for use, specifically associated with continuous and intermittent mode settings.The customer stated they will share education materials and quick reference guides to all mercy health facilities.No further corrective actions are required at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• 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; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22563958
• Report Number: 1423537-2025-00287
• Device Sequence Number: 21141617
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: (01)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): 09/23/2025

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?: 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: 06/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown