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

Model Number 482400S

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem 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 states that the enteral feeding pump failed the motor speed test.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states, ¿fails motor speed test¿.The unit was triaged and the customer¿s reported condition was confirmed.The service technician found the pump had a defective sensor.A trend has been identified and a corrective action has been opened to address this issue.A review of the device history record shows that this unit was manufactured in 2011 and was released meeting all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 789 puxing rd; building 10; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN; 789 puxing rd; building 10; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7428944
• MDR Text Key: 105520621
• Report Number: 3006451981-2018-00273
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482400S
• Device Catalogue Number: 482400S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• 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