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

Model Number 775659

Device Problems Disconnection (1171); Unintended Ejection (1234)

Patient Problem Pain (1994)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

Kangaroo pump alarmed feeding error, and rn noted that the tube feeds were leaking onto the floor.When i opened the kangaroo pump door, the tubing had become disconnected inside the door, and the patient side was full of air.Patient complained of stomach pains, tube feeding disconnected and held.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 300 south riverside plaza; chicago IL 60606
• MDR Report Key: 9710984
• MDR Text Key: 179434428
• Report Number: 9710984
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2020,01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 192660146
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2020
• Date Report to Manufacturer: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26280 DA