MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 383400

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/25/2017.

Event Description

It was reported to covidien that a customer had an issue with an enteral feeding pump.Upon triage on (b)(6) 2017, service found that the unit had a ruptured component from potential overheating.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of, ¿the customer reports the unit is not working.Upon triage, the service tech found the unit had a ruptured component from potential overheating.¿.The unit was triaged and the reported issue was confirmed.The potential root causes are the use of an unauthorized power adapter by the user and a possibly defective component.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: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6519113
• MDR Text Key: 73612194
• Report Number: 1282497-2017-05104
• 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: 11/06/2017

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: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: 06/07/2017
• Supplement Dates FDA Received: 11/06/2017
• 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: Initial
• Patient Sequence Number: 1