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	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the rn, who had the patient until 1900, reported that she changed the tubing in the evening and that the pump was running fine.She appropriately charted on the lda for her 1600 charting as well.She changed the pump shortly before shift switch.When the night team came into the room at 2000, they noted that the pump was off.They turned the pump back on, checked the patient's sugar, and found it to be in the 30s.They gave her dextrose, and the patient recovered without any symptoms or issues.They asked the staff who were in the room from 1900-2000, and they don¿t recall seeing the pump off or on, they weren¿t really checking.They checked the pump and saw that it had run 100 cc since the rn from day shift changed the tubing, meaning her story tracks.When she changed the tubing, it was running fine.Contributing factors: patient has had disproportionate number of hypoglycemic events during her admission.The staff have suspicions of this patient perhaps sabotaging her own feeds in the past, but they don't think the patient did this time.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed, and no discrepancies were noted.The device passed all testing.The pump was received for evaluation.Accuracy testing on the pump showed there was no evidence of feeding accuracy issues.The device passed service certification.This was the first time the device received service.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: 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: 21925415
• Report Number: 1423537-2025-00186
• Device Sequence Number: 4008847
• Product Code: LZH
• UDI-Device Identifier: 10192253065701
• UDI-Public: 10192253065701
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/13/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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: Unknown