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

Model Number 382400

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 the unit had a burnt hole in the rear case.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states ¿ issues with intermittent display.Upon triage on 2/20/2017 service found the unit had a burnt hole in the rear case.¿ the unit was triaged, the customer complaint was not verified, though a different problem was found.The unit was powered on and the unit did not present with any issues.The unit was connected to a feed/flush set and allowed to run for a short while.The unit ran with no errors.It was noticed that the display was not absent from the edges.The unit did not shut down though.The unit was disassembled and investigated.The unit had ingress on the pcb.Moreover, the capacitor, was burnt along with its neighbor components.The part of the rear housing behind this capacitor has a protruding, which was also burnt.The attempt to run the unit (in order to check for intermittent power) was not made afterwards because of the thermal issue on the board.Disposition unit due to being to costly to fix.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 EPUMP - NEW
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6399108
• MDR Text Key: 70059745
• Report Number: 3006451981-2017-00203
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• 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: Unknown
• Patient Sequence Number: 1