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

Model Number	385400
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the device has been glitching.It is not turning on when plugged in.Additional information was provided.The issue started after some time of use, but the time would vary.It was reported to be stopping around mid-feed and right after the pump would start.The device would turn on by itself.It would display error codes (air in line, occlusion error, system error 10).The patient's caretaker would start the pump, the pump would confirm "started", but feeding would not occur.The device was manually turned off.Patient's family reported that in the past, this pump would unexpectedly power off on its own, but not in this specific incident.No harm has been reported; however, the patient was sent to the hospital in the time period due to vomiting.Further information was provided stating that the issue resulted in inaccurate feedings.Unfortunately, the caregiver does not have specific volumes.No actual air was found in the line.The patient's mother suspects the vomiting is likely related.The patient was hospitalized and was stabilized.The patient is currently feeding on another unit (a kangaroo joey pump) and is stable.The patient was not harmed.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A review of the service history record determined this is the first time the device has been returned for service.The device was received for evaluation and testing was performed.The reported issue could not be duplicated, the device operated as intended.

• 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; 651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24313222
• Report Number: 1423537-2026-00034
• Device Sequence Number: 4837634
• 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): 04/08/2026

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?: No
• Device Model Number: 385400
• Device Catalogue Number: 385400
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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: Hospitalization
• Patient Sex: Unknown