MAUDE Adverse Event Report: COVIDIEN INT KANGAROO EPUMP X1; ENTERAL FEEDING PUMP

Model Number 482400J

Device Problems Device Alarm System (1012); No Flow (2991); Power Problem (3010)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/19/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that the customer experienced an issue with an enteral feeding pump.The customer reports that the unit does not detect a flow.The customer also reports there is an issue with the alarm's power.No additional information was provided after follow-up was performed on 09/13/2016, 09/15/2016, and 09/19/2016.

Manufacturer Narrative

Submit date: 02/15/2017.An evaluation of the kangaroo epump was performed for the reported condition of the unit not detecting a flow and an issue with the alarm's power.The unit was triaged and the reported issue could not be confirmed at this time.A review of the device history record shows that this unit was manufactured in 2015 and was released meeting all manufacturing specifications.

• Brand Name: INT KANGAROO EPUMP X1
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5959576
• MDR Text Key: 55356400
• Report Number: 1282497-2016-00702
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 482400J
• Device Catalogue Number: 482400J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2017
• 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