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

Model Number	385400
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Dehydration (1807)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the pump is not giving the programmed flush during tube feeding.This has contributed to worsening renal function.The patient was started on iv fluids when iv access became available, as the patient had difficult vasculature.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record and service history review could not be performed because no serial number was provided.The unit was not returned for service.If the information becomes available, the applicable service notes will be updated.A root cause and corrective actions could not be determined with the available information.No further action is needed at this time.We will continue to monitor reports and take action as applicable.

• Brand Name: KANGAROONG PUMP
• 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: 21938226
• Report Number: 1423537-2025-00187
• Device Sequence Number: 18102262
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: 10192253065701
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K221603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown