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 No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2019

Event Type  malfunction  

Event Description

Kangaroo enplus spike with flush bag tubing leaking at tube feeding bottle insertion site.Manufacturer response for kangaroo pump tubing, kangaroo epump enplus spike with flushing bag (per site reporter): (b)(4) notified.(b)(4) referred me to (b)(4) health.Service sales representative requested i contact [x] via email.Email to (b)(6) for reporting an equipment failure.Equipment sent to (b)(6) via (b)(6).(b)(6) indicated she will make sure it is sent to (b)(4) health quality lab for testing.

• Brand Name: KANGAROO EPUMP ENPLUS SPIKE WITH FLUSH BAG
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; building 5; mansfield MA 02048
• MDR Report Key: 8543440
• MDR Text Key: 142880730
• Report Number: 8543440
• 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: 04/23/2019,04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 190740229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA