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

Model Number JOEY

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Event Description

In 2017, it was reported that 45 feeding pumps were removed from service for various reasons.Ten (10) of the 45 pumps were returned to the manufacturer for issues related to broken door/hinge.The 35 remaining pumps were removed from service for various reasons.Reportedly, no harm occurred to patients.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• MDR Report Key: 6405706
• MDR Text Key: 69978858
• Report Number: 6405706
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JOEY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1