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

Model Number 773656

Device Problems Inaccurate Delivery (2339); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); Mechanics Altered (2984)

Patient Problems Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Submit date: 09/08/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an adverse event with an enteral feeding pump set.The customer reports the connector is designed so small it takes her feeding time twice as long.The customer further states that the device harbors bacteria.As a result, she has had 10 infections.The customer states that she had to take a lot of antibiotics which did not clear up her infection.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Two unused samples were received.A functional test was performed and the samples worked as intended; 1,000 ml of water was put into both bags with a feed rate of 400 ml/hr.And both bags finished at the same time.The reported issue could not be confirmed.All feeding bags are manufactured according to design specifications and should be used with the recommended liquid formulas.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.A good faith effort will be made to obtain the applicable information relevant to the report.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; 37 insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5936971
• MDR Text Key: 54225408
• Report Number: 1282497-2016-00675
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention