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

Model Number	B10FF
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the valve is not sealed properly and is pulling air into the feeding side, filling the consumers stomach with air.This is causing the pump to go back into the flush mode, due to air bubbles in the feed line.Pump forces priming before it will return to feed mode.
Additional Manufacturer Narrative
The device history record showed all acceptance criteria inspections were within acceptable limits during the production process.No sample was received for evaluation; therefore, a root cause could not be determined.The current manufacturing activities are running according to product specifications, meeting quality acceptance criteria, validation process, and released procedures.We will continue to monitor and take actions as applicable.

• 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; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22649445
• Report Number: 1423537-2025-00294
• Device Sequence Number: 21036703
• Product Code: LZH
• UDI-Device Identifier: 10885380177118
• UDI-Public: (01)10885380177118(17)291231(10)2500207964
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B10FF
• Device Catalogue Number: B10FF
• Device Lot Number: 2500207964
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown