MAUDE Adverse Event Report: COVIDIEN KANGAROO ENTERAL FEEDING PUMP SET 1000ML; PUMP, INFUSION, ENTERAL

Catalog Number 773656

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

Feedbag tubing snapped; feeds went all over floor; rn had to hang new bag.

• Brand Name: KANGAROO ENTERAL FEEDING PUMP SET 1000ML
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 4222465
• MDR Text Key: 5070719
• Report Number: 4222465
• 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
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2014
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 70