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

Model Number 382400

Device Problem Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/30/2017.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 states that the enteral feeding pump's battery wires had a small amount of exposed copper where the insulation was cut.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states, ¿failed mistic test.¿ the unit was triaged and the service technician found the battery was damaged with exposed wire cut insulation.The pump was excessively damaged, so the root cause is categorized as 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
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 789 puxing rd; building 10; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN; 789 puxing rd; building 10; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6597682
• MDR Text Key: 76157257
• Report Number: 3006451981-2017-05291
• 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: 06/21/2018

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 Expiration Date: 01/30/2023
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 05/30/2017
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2013
• 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