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

Model Number	385400
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/12/2024
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 a patient was receiving a bolus feed via his omni feeding pump through his g-tube.The pump kept alarming that it was clogged.The patient's parents were able to by-pass the alarm, and the pump reported that it had delivered his full 90ml feed.However, it did not.As a result, the patient's blood sugars dropped to 3.2mmol/l quickly.The patient has a dexcom continuous glucose monitor because of a metabolic condition (glycogen storage disease type 1b) where he is not able to fast without receiving exogenous glucose to maintain his blood sugars.The monitor alerted the parents of the dropping blood sugar.
Additional Manufacturer Narrative
A non-conformance or service history review (shr) could not be conducted as no lot or serial number was provided with the complaint.The unit was not returned for evaluation; 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 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21405263
• Report Number: 1423537-2025-00085
• Device Sequence Number: 12892730
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: (01)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): 03/12/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/12/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male