MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 383400

Device Problems Insufficient Flow or Under Infusion (2182); Inappropriate or Unexpected Reset (2959)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported the enteral feeding pump does not keep the volume and the speed set by the user.It always ends before the time set.No further information is available at this time.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states ¿the enteral feeding pump does not keep the volume and the speed set by the user.It always ends before the time set.¿ 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.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 7681702
• MDR Text Key: 114067081
• Report Number: 1282497-2018-00577
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1