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

Model Number 775100

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2019

Event Type  malfunction  

Event Description

Multiple tube feeding bags leaking at the connection between the tube feeding bag and the connection.

Event Description

Multiple tube feeding bags leaking at the connection between the tube feeding bag and the connection.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 300 south riverside plaza; suite 2010; chicago IL 60606
• MDR Report Key: 8868956
• MDR Text Key: 153531173
• Report Number: 8868956
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: (01)10884521155817
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 170550287
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2019
• Patient Sequence Number: 1