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

Model Number 383400

Device Problem Insufficient Information (3190)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date 2/14/17.

Event Description

The customer states that the unit has a blank display.There is no additional information available per the customer's response to a request for additional information.

Manufacturer Narrative

As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The unit was sent to a service center for repair.Upon triage, the technician could not duplicate the customer complaint of blank display.The unit was powered up.Ac power was connected and the unit was observed to charge.A feed/flush set was connected and the unit started feeding.The unit was allowed to feed overnight.No issues were observed with the display.Recertification testing was performed and the unit passed.The unit was disassembled and visual inspection found contamination on the display and potential contamination on the main pcb.The unit has been repaired, and recertified per procedure.The unit was restored to proper operation.

Event Description

The customer states the unit has a blank display.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6329131
• MDR Text Key: 67385331
• Report Number: 3008361498-2017-05013
• 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: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2014
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• 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