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

Model Number	B5FD
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
Event or Problem Description
The customer reported the pump is pulling air through instead of milk.Biomed found when they hooked up the cassette, as soon as the pump started and it tried to lock the cassette on, it pushed the cassette away making it sit at a weird angle.The cassette seems to have a bit of deformity on the inner plastic part.They found the issue seemed to be the combination of the affected cassette and the pump.The cassette on a different pump does not have the issue, and the pump with a new cassette does not have the issue.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record review could not be performed because no lot number was provided.Two videos and one picture were provided for evaluation.Through the videos and picture provided, it was not possible to confirm the reported condition related to air in the line, and it was not possible to visibly observe through the picture any damage to the plastic or to deduce if the sample meets the quality acceptance criteria.The investigation was conducted with the cross-functional team and found that all processes and controls were followed correctly.Based on current information, reviewing the videos and picture, without further investigation of a sample, the root cause or source that originated the reported condition could not be determined.To raise awareness, personnel were notified of the reported failure mode.We will continue to monitor complaint notifications and customer feedback for adverse trends that require immediate attention.

• 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: 21322419
• Report Number: 1423537-2025-00065
• Device Sequence Number: 8603822
• Product Code: LZH
• UDI-Device Identifier: 10885380177125
• UDI-Public: (01)10885380177125
• 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): 03/06/2025

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: B5FD
• Device Catalogue Number: B5FD
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown