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

Model Number	382400
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/19/2025
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 customer reported that the device was overfeeding.The volume to be infused set to was 400ml q6 (every 6 hours).The reported amount was 700ml delivered within 3.5 hours.The feeding was stopped prior to completion.The patient had an elevated sugar level.They performed manual tube feeding.No error codes were shown.Additional information received stated the patient is a diabetic.The blood sugar is not available.Insulin was administered by the nursing staff.
Additional Manufacturer Narrative
The service history record review showed this was the first time the pump was returned for service.The unit was received and evaluated as part of our investigation.The functional testing was able to duplicate the reported issue.The root cause could not be determined.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, INC; 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: 21761397
• Report Number: 1423537-2025-00154
• Device Sequence Number: 8676357
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: (01)10884521006614
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040196
• 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): 04/18/2025

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: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/18/2025
• 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
• Patient Sex: Unknown