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

Model Number 382401

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/18/2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to covidien that a customer had an issue with the enteral feeding pump.Upon triage of the unit, on (b)(6) 2018, service found that the unit had an illegible display.Only the unit¿s led lights flickers intermittently with battery power for a few seconds.The display was blank.

Manufacturer Narrative

The unit was triaged and the customer¿s reported condition was confirmed.The root cause root cause was isolated to an excessive cor rosion on components.Liquid ingress caused the pcba to corrode, and is the result of customer misuse.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.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: 7441311
• MDR Text Key: 105909736
• Report Number: 3008361498-2018-00215
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

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: 382401
• Device Catalogue Number: 382401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1