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

Model Number 382400

Device Problems Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien that a customer had an issue with an enteral feeding pump.On (b)(6) 2016 the customer states the unit displayed a system error.Upon triage on (b)(6) 2016 the service tech found the unit rendered inaccurate volumes during testing.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed, upon triage a condition of, on (b)(6) 2016 the service tech found the unit rendered inaccurate volumes during testing.A trend has been identified and a formal 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 EPUMP - NEW
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• MDR Report Key: 5990051
• MDR Text Key: 56492728
• Report Number: 3006451981-2016-00453
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

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: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: 09/26/2016
• Supplement Dates FDA Received: 08/15/2018
• Patient Sequence Number: 1