MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/POLE CLMP; ENTERAL FEEDING PUMP

Model Number 383400

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation was currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an enteral feeding pump.The customer reports that the unit is pumping air after the feed.No patient involvement.

Manufacturer Narrative

Submit date: 10/26/2016.An investigation of kangaroo epump was performed for the reported condition of; the unit is pumping air after the feed.The unit was triaged and the complaint was confirmed.The cause of the reported condition was due to the unit¿s sensor; the unit¿s sensor was replaced to correct the issue.The unit was then fully tested; unit passed all testing.The unit was manufactured in 2012.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5689753
• MDR Text Key: 46307994
• Report Number: 1282497-2016-00277
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Device Lot Number: F1250549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• 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