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

Model Number	B10FD
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 that after a few months the pump started passing air.When there was air in the tubing, there was no message and the device continued.The pump started showing error #8, then defective cassette.This happened while feeding the patient.The cassette issue happened with a new bag that was working then suddenly the pump indicated that it was no longer working.Additional information received stated the pump lets air up to 6 cm long pass through without an error message.
Additional Manufacturer Narrative
The device history record was reviewed and indicated the product was released accomplishing all quality standards.No samples were returned for evaluation.The root cause could not be determined, and no further action is needed at this time.We will continue to monitor reports and take action 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: 22025781
• Report Number: 1423537-2025-00203
• Device Sequence Number: 9125402
• Product Code: LZH
• UDI-Device Identifier: 10885380177101
• UDI-Public: (01)10885380177101(17)261130(10)2333805964
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: B10FD
• Device Catalogue Number: B10FD
• Device Lot Number: 2333805964
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown