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

Model Number 383400

Device Problem Output Problem (3005)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/10/2017.

Event Description

The customer states that there is an issue with the volume being delivered.Additional information has been requested with no response to date.

Manufacturer Narrative

As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The unit was sent to a service center for repair.Upon triage, a technician found no obvious issues.The pump powered up with no anomalies noted.The pumps volume function was checked with no issues identified.The pumps volume to be delivered function was tested.The pump was programed to deliver 125 ml of water at a rate of 125 ml/hour.At the end of the feed cycle the pump delivered 143 ml of water (the specification for this test is 121.25 ml to 138.75 ml) which is out of specification.The reported condition of volume issue, the amount being infused, was verified through duplication.The unit has been repaired, and recertified per procedure.The unit was restored to proper operation.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6322404
• MDR Text Key: 67268395
• Report Number: 1282497-2017-05017
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• 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: Initial
• Patient Sequence Number: 1