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

Model Number	775100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare provider went through multiple kangaroo pumps in 4n14 then tried switching the tubing.Error message kept stating there was a flow error.Healthcare provider tried both the standard spike set with a bag and the double bag.The double bag worked.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 19258345
• Report Number: 19258345
• Device Sequence Number: 20503208
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: (01)10884521155817
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/15/2024
• Report Date (Section F): 03/15/2024

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: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 2327200228
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• 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: Unknown
• Date Report Sent to FDA: 03/15/2024