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

Model Number	385400
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/24/2025
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 a system alarm 08 on the pump.Additional information was received stating that at 0800, the resident's accucheck was 6.2.They poured the scheduled tube feed and attached to the resident's gt port.Scheduled insulin glargine 14 units was administered to the resident.The pump was turned on and started.Initially, the screen showed "flushing 75/150ml".They left the room.At 1105, the accucheck was checked as scheduled and showed 3.8.They checked the resident in the room and the resident showed no objective and subjective symptoms of hypoglycemia other than the blood sugar.They checked the pump and saw that the pump was still "flushing 75/150ml".They assumed that the pumped never flushed the line and the 0830 tube feed never ran through as the bag remained full.They re-programmed the pump to infuse the tube feed.At 1220, the accucheck was rechecked and showed 3.5.Hypoglycemia protocol was followed and they administered 15gm of glucose gel via gt.The incident was reported off to another nurse as the first went for a break.After 15 minutes, the nurse re-checked the accucheck of the resident and it showed 3.0.The nurse assessed the tube feed pump and site and noticed that the purple port was disconnected from the tube, and the tube feed had been infusing out of it.Tube feed residue was noted on the green pad.The nurse re-connected the port to the tube and continued to infuse the remainder of the 0830 pump + 1 box from the scheduled 1230h feed.The nurse re-checked the accucheck at 1300 and it showed 4.4.
Additional Manufacturer Narrative
This is the first time that this device came in for service.Upon receipt of the device for evaluation, the device was tested and the reported issue could not be duplicated, the results were within specification and the device operated as intended.The alarm history records for ks23w0027110 were reviewed and showed the device never had a system error 8 or any other motor, cassette, or valve error.A definitive root cause could not be determined as the testing of the device was within specification.

• 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: 23631385
• Report Number: 1423537-2025-00476
• Device Sequence Number: 18714975
• 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): 03/25/2026

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: 11/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/25/2026
• 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: Unknown