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

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2013

Event Type  malfunction  

Event Description

Noted pump roller wheel missing.Upon exam, no visible damage to case, wheel placement is behind door.Assumption that wheel must have fallen off when feeding tubing removed.Assumption that small screw that holds wheel in place was not sufficiently tightened.Biomed replaced pump wheel and evaluated other pumps in stock to ensure appropriate tension to wheels.

• Brand Name: KANGAROO EPUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 4143094
• MDR Text Key: 4911777
• Report Number: 4143094
• 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: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2014
• Device Age: 2 YR
• Date Report to Manufacturer: 10/06/2014
• Patient Sequence Number: 1