MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; TUBE, FEEDING

Device Problems Disconnection (1171); Leak/Splash (1354); Air/Gas in Device (4062)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

During handoff this rn was notified that the patient had developed nausea and vomiting overnight which required a prn order for zofran.On assessment early in the am, this rn noticed feeds leaking from the kangaroo pump.It was noted that the plastic tubing exiting the purple cartridge that plugs into the kangaroo pump had become partially dislodged.This area of disconnection was allowing the enteral feeds to exit the patient's tubing as well as intaking air which was then being pumped through the tubing into the patient's stomach.This could have been a contribution to the patient¿s nausea and subsequent vomiting that led to two doses of zofran being given and a delay in her morning medications.

• Brand Name: KANGAROO
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16381336
• MDR Text Key: 309611535
• Report Number: 16381336
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/30/2023,01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5475 DA