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

Model Number 775100

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2020

Event Type  malfunction  

Event Description

Spike broke off knob on the epump enplus spike with flush bag tube feeding set.This has happened twice on two different tubing sets.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 444 mcdonnell blvd.; hazelwood MO 63042
• MDR Report Key: 10867707
• MDR Text Key: 217101722
• Report Number: 10867707
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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: 202230378
• 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: 10/16/2020
• Event Location: Other
• Date Report to Manufacturer: 11/19/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA