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

Catalog Number 773656

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/30/2014

Event Type  malfunction  

Event Description

Feeding pump noted to "chew holes" into feeding bag tubing causing feeding pump to alarm "occlusion" upon inspection formula coming out of tubing where tubing links into feeding pump rotator.Pump being evaluated by hospital biomed.

• Brand Name: KANGAROO ENTERAL FEEDING PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 3755373
• MDR Text Key: 4470538
• Report Number: 3755373
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 773656
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1