MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO EPUMP ENPLUS SPIKE WITH FLUSH BAG; PUMP, INFUSION, ENTERAL

Model Number 775100

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 07/18/2020

Event Type  malfunction  

Event Description

Tube feeding was leaking on the outside of the spike set tubing.This is a recurrent issue.The tf bag was spiked correctly.This is an ongoing issue.

• Brand Name: KANGAROO EPUMP ENPLUS SPIKE WITH FLUSH BAG
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10572877
• MDR Text Key: 208130970
• Report Number: 10572877
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 201390157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1