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

Model Number 383400

Device Problem Device Stops Intermittently (1599)

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

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer stated that the unit will only work with the power supply and shuts off randomly.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition shuts off randomly.The unit was triaged and the reported issue was confirmed.The root cause of reported condition was due to a worn battery.This is typical routine maintenance.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; building # 10, 789 puxing road; shanghai,cn 86-21 -240; CN 86-21-2408
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai,cn 86-21 -240; CN 86-21-2408
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6489338
• MDR Text Key: 72661624
• Report Number: 3011410703-2017-00101
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2013
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• 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