MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO EPUMP SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL

Model Number	775659
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We have had at least 6 incidents since august, most occurring in november, of kangaroo tubing bursting and spilling: patient was connected to tube feeding pump at a rate of 90ml/hr.Tube feeding tubing burst open and leaked tube feeding everywhere.Tubing burst open at a connection on the tube feeding tubing.Tubing has been saved.Tube feeding pump malfunctioned for a patient that is on an insulin drip.The tubing inside was separated at the turn wheel so the tube feeding ended up leaking out through that opening but the machine kept running.Rn noticed a large pooling of tube feedings on the floor and switched the tubing.The nasoduodenal tube ended up getting clogged because the tube had dormant tube feeding sitting in it for unknown amount of time.Nasoduodenal tube was able to be unclogged with warm water.The tubing was changed and this problem occurred a second time where the tubing broke in half at the wheel.New pump was ordered and blood sugar remained stable.Kangaroo epump tubing broke off at connection site.Tube feeds leaked all over.Kangaroo epump tubing broke off at connection site.Tube feeds leaked all over.Tubing saved and given to cns.This is the second time (in a different room) that this happened today.Kangaroo tube feeding set came apart inside the pump when flushing the feeding tube.This is a known issue that is being addressed.This event is being submitted for continued awareness that the problem exists.Rn was giving a medication through the red/side port of the ngt and the tubing that is located inside the feeding tube pump exploded.

• Brand Name: KANGAROO EPUMP SAFETY SCREW SPIKE SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16060669
• Report Number: 16060669
• Device Sequence Number: 6733133
• Product Code: LZH
• UDI-Device Identifier: 10884521155831
• UDI-Public: 10884521155831
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2022
• Report Date (Section F): 12/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 2212900664
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2022
• 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: 12/02/2022