MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; PUMP, INFUSION, ENTERAL

Model Number	482400J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Date of Event	10/25/2024
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 that the device over feeds.The feeding of the child was programmed as a 6-hour feed overnight, but it completed in 3-4 hours causing the child to be sick.Additional information received stated the child was on a formula combination of ketovie peptide, rcf concentrate, oil, and water.This is prepared and refrigerated prior to use.He has been on a version of this recipe for 12 years, administered via the kangaroo pump.Volume was set to between 400 and 600 mls at each feed.Rate was set at 100 mls/hr during the day and 75 mls/hr at night.The volume delivered was not consistent to the volume set.It always ran faster than the set rate.The patient was sensitive to the feed rate.It caused vomiting and stomach upset.The patient was suctioned and repositioned to avoid vomiting and aspiration.The vomiting happened over a 24-hour period and occurred intermittently when the feed rate was not monitored and manipulated to solve for the fast pump.There was no medication provided for the vomiting.The feed was paused which delayed the nutrition.To ease the stomach upset, tylenol and tube venting was provided.The patient is okay after properly managing feed rate and volume.
Additional Manufacturer Narrative
The service history showed this is the third time that this device came in for service.The unit was tested and operated as intended.There were no issues found that could have contributed to the reported issue.The reported issue could not be duplicated; therefore, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 20747722
• Report Number: 1423537-2024-00320
• Device Sequence Number: 18305078
• Product Code: LZH
• UDI-Device Identifier: 10884521174818
• UDI-Public: (01)10884521174818
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040196
• 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): 01/07/2025

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: 482400J
• Device Catalogue Number: 482400J
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male