MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL

Model Number 383401

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Customer states that the enteral feeding pump failed the flow sensor test during testing.Patient involvement is unknown.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of, ¿the enteral feeding pump failed the flow sensor test during testing.¿ the unit was triaged and the customer¿s reported condition was confirmed.A trend has been identified and a corrective and preventative action has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• MDR Report Key: 7317716
• MDR Text Key: 101717184
• Report Number: 3008361498-2018-00128
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1