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

Model Number 775659T

Patient Problem Insufficient Information (4580)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

3 separate instances of primary rn reporting difficulties with tf administration.New tubing and tube feed primed on several occasions without success of pumping ringing flow error.New pump obtained.Flow error continues to occur.*patient on insulin gtt.Interruption of tf administration puts patient at risk of hypoglycemic event.Per rn patient has been difficult to find optimal dose of insulin due to the frequent and random flow errors that have been occurring.Kangaroo epump enplus spike set being used.Ref 775659t.Kangaroo pump in use in room.Dht 10fr.Followed up with nsicu team about the event.Information gathered regarding the tubing sets.Product reference 775659t and the lot number of one of the sets the nurse tried is 22b194fhy.Reached out to cardinal health representative requesting assistance to look at tubing sets and tube feeding kangaroo pumps.Awaiting response from cardinal health.Work orders placed by the clinical team for the kangaroo pumps for clinical engineering to evaluate.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17984993
• MDR Text Key: 326266805
• Report Number: 17984993
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2023,08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 775659T
• Device Catalogue Number: 775659T
• Device Lot Number: 22B194FHY
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1