MAUDE Adverse Event Report: COVIDIEN JAPAN KANGAROO CONTRL PUMP; ENTERAL FEEDING PUMP

Model Number 8884362410

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/12/2017.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with an enteral feeding pump.The customer states during testing the margin of flow volume was large.No patient involvement.No further information is available.

Manufacturer Narrative

Submit date: 03/14/2017.An evaluation of the kangaroo pump was performed for the reported condition of the unit's margin of flow volume was large.The unit was triaged and the reported issue could was not confirmed.The unit passed all testing.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.

• Brand Name: JAPAN KANGAROO CONTRL PUMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6245078
• MDR Text Key: 65069446
• Report Number: 3008361498-2017-00040
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

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: No Information
• Device Model Number: 8884362410
• Device Catalogue Number: 8884362410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2017
• 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