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

Model Number	482400J
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a 500 cc hydration pouch was connected via a y-connector with enteral nutrition pouches (sondalis energy 500 cc and sondalis energy fibre 500 cc) to a gastrostomy tube.The 500 ml of water was administered over 1 hour instead of 10 hours due to incorrect programming of the kangaroo pump (bolus rinse volume) by the visiting nurse.The patient received a single 500 cc rinse bolus instead of 10 boluses of 50 cc over 10 hours.The patient was hospitalized on day 3, for bronchopulmonary disease possibly related to an error hydration flow rate on a gastrostomy tube, in a context of significant fragility (inhalation pneumonitis at repetition, history of resuscitation, limitation of care).
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The service history record was reviewed, and there was no previous information available for this device.The device was not returned for evaluation; however, the customer stated the device was programmed incorrectly by the visiting nurse.Without the product, a detailed investigation could not be performed and the reported condition could not be confirmed.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.We will continue to monitor and take actions as applicable.

• 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: 22902683
• Report Number: 1423537-2025-00349
• Device Sequence Number: 18375751
• Product Code: LZH
• UDI-Device Identifier: 10884521174818
• UDI-Public: 10884521174818
• Combination Product (Y/N): N
• Initial Reporter Country: RE
• 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): 10/09/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown