MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - RFB; ENTERAL FEEDING PUMP

Model Number 382401

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/06/2016.An investigation is currently underway.Upon completion, a full report shall be provided.

Event Description

It was reported to covidien on (b)(6) 2016 that the customer experienced an issue with an enteral feeding pump.Customer alleges that the line on the unit will not feed.

Manufacturer Narrative

Submit date: 11/03/2016.An investigation of kangaroo epump was performed for the reported condition of; the line on the unit will not feed.The unit was triaged and the complaint was confirmed.The cause of the reported condition was due to damage to the unit¿s gearbox.The unit¿s gearbox was replaced to correct the issue.The unit was then fully tested; unit passed all testing.Kangaroo epump was manufactured in 2008.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: KANGAROO EPUMP - RFB
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5701477
• MDR Text Key: 47840855
• Report Number: 1282497-2016-00323
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382401
• Device Catalogue Number: 382401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1