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

Model Number 382400

Device Problems No Audible Alarm (1019); Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported issue could not be duplicated.There was no issues found with the unit.The unit passed triage and the recertification test.The unit has been cleaned, repaired, tested and recertified per procedure.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 routine basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.

Event Description

The customer an issue with their enteral feeding pump.Upon communication with the customer, on (b)(6) 2017, it was mentioned that th e pump's wheels were not turning and the pump did not alarm.No additional information was available.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6848891
• MDR Text Key: 85142376
• Report Number: 3006451981-2017-05579
• 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
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2014
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Date Manufacturer Received: 03/28/2017
• 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