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	Hypoglycemia (1912)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the device is under delivering.The patient's blood glucose fell to hypoglycemic range again, at which time the mom noticed that although the feed pump indicated the drip was infusing, the volume delivered remained unchanged for what was likely 1-2 hours.If the feeding pump had been infusing, the patient would have successfully weaned from the iv.Instead, this led to an admission.Additional information: this patient has a condition called glycogen storage disease type 1a, in this condition patients require a constant source of carbohydrate to prevent life threatening hypoglycemia.During the stay in the ed, the plan was to wean the patient off iv dextrose by having continuous ng tube feeds running.The tube feed pump indicated the drip was infusing at the goal rate; therefore, the iv dextrose rate was decreased to a low rate for discontinuation.Blood glucose fell to the hypoglycemic range, therefore the iv was increased back up and the ed planned to admit the patient to the unit in view of being unable to wean them off the iv due to hypoglycemia.When they were transferred, the iv tube broke and dextrose was spilling on the floor.The feeding pump continued to appear to be running.Blood glucose fell to hypoglycemic range again, at which time mom noticed that although the feed pump indicated the drip was infusing, the volume delivered remained unchanged for what was likely 1-2 hours.If feeding pump had been infusing, she would have successfully weaned from iv.Instead, this led to an admission which could have been avoided.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Upon receipt of the device for evaluation, an accuracy test was conducted, and the results were within specification, the device operated as intended.During the evaluation of the device, the alarm records for the prior 30 days were reviewed.The information received indicated the event occurred on (b)(6) 2025.The alarm records pulled off the device show 4 alarms were triggered on (b)(6) 2025: ¿ system error at 16:27pm gmt (10:27am mdt).¿ system error at 16:48pm gmt (10:48am mdt).¿ inactivity notification at 20:50pm gmt (2:50pm mdt).¿ inactivity notification at 21:33pm gmt (3:33pm mdt).The time the reported issue occurred was not provided by the customer; therefore, we cannot determine whether any of the above alarms contributed to the user not being fed.It is unknown what triggered the system errors or if the pump was actively operating at the time of the errors.However, we can confirm the pump was in a powered-on condition when the system alarms were generated.To clear these system alarms, the device would have to be powered down and then powered back up to resume or begin operation.The inactivity alarm occurs when the device is powered on, not feeding, and it has been more than 10 minutes since the last interaction with the device.A definitive root cause could not be determined as the accuracy testing of the device was within specification.However, a possible root cause could be that when the alarms were triggered, the user may not have pressed start before walking away from the device.This could have contributed to the user not being fed.

• 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: 23392184
• Report Number: 1423537-2025-00429
• Device Sequence Number: 18628326
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: 10192253065701
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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: Other
• Patient Sex: Unknown