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

Model Number	385400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Gastrointestinal Problem (4491)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the patient has a serious fatty acid oxidation disorder requiring a minimum amount of calories to prevent or treat severe rhabdomyolysis.She requires continuous nocturnal feeding to prevent catabolism and subsequent symptoms of rhabdo.When ill or during times of rhabdo, she required continuous feeds to treat or prevent exacerbation of rhabdo.On the night on (b)(6) 2025 her nocturnal feeds were set and started on the pump as usual.In the morning it was discovered that the feeds did not run through the pump and the feed bag was still full.As a result, the patient had significant symptoms of rhabdo.This is a new omni pump that was switched on (b)(6) 2024 for another omni pump for similar reasons.If the patient has rhabdo and requires continuous feeds throughout the day, her pump usually runs during the school day so she doesn't miss school.Since the pump was switched on (b)(6) 2024, she has missed ~5 days of school because the pump continues to alarm all day and disturbs the class.Therefore, she has been missing school so she can have her continuous feeds during the day without disturbing others.
Additional Manufacturer Narrative
The device history record was reviewed, and the device was functioning as intended at the time of initial release.A root cause and corrective action is not applicable because the reported device was not returned to the service center for investigation.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; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21730241
• Report Number: 1423537-2025-00146
• Device Sequence Number: 4046339
• 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): 05/12/2025

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: 03/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/12/2025
• 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
• Patient Sex: Unknown