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

Model Number 383401

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2017-06-27.

Event Description

According to the reporter, on (b)(6) 2017, during the testing of the device was returned for it keeps turning on and off.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of turns on and off.The unit was triaged and the reported issue was confirmed.The pump was found to have a damaged printed circuit board.The unit has been repaired, and recertified per procedure.The unit was restored to proper operation.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 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: 6670606
• MDR Text Key: 78674108
• Report Number: 3008361498-2017-05233
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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 Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 07/11/2017
• Supplement Dates FDA Received: 11/10/2017
• 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