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

Model Number	B10FD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pump set to infuse/deliver feeds at 59ml/hr.Rn (registered nurse) went in as pump was ringing occlusion.When rn looked at feed bag, almost all of the 240mls she had just placed in the bag was gone (approximately 200mls).Device said 1ml delivered.Delivered via j-tube.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 21207219
• Report Number: 21207219
• Device Sequence Number: 12780140
• Product Code: LZH
• UDI-Device Identifier: 10885380177101
• UDI-Public: (01)10885380177101(17)270731(10)2424100964
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/15/2025
• Report Date (Section F): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B10FD
• Device Catalogue Number: B10FD
• Device Lot Number: 2424100964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 01/15/2025