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

Model Number 482400

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states, ¿overheating".The unit was triaged and the reported issue could not be confirmed at this time.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.

Event Description

Customer reports that the overheating of the front part of the enteral feeding pump.No patient was involved.No further information available.

Manufacturer Narrative

The unit was triaged and the reported issue could not be confirmed at this time.A review of the device history record shows that this unit was manufactured in 2008 and was released meeting all manufacturing specifications.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
• Manufacturer (Section G): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7659023
• MDR Text Key: 113170915
• Report Number: 3008361498-2018-00366
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482400
• Device Catalogue Number: 482400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2008
• 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