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

Model Number 461243

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pneumothorax (2012)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.

Event Description

The customer states that the iris feeding tube was placed blindly (without use of the video console).The patient received the tube on (b)(6) 2017 and the tube was removed on (b)(6) 2017.When the nurse placed the iris tube it caused a pneumothorax.

Manufacturer Narrative

A device history record review could not be performed because the serial number was not provided by customer.There was no sample returned for evaluation, thus the visual/function test against the reported failure was not able to be performed.Based on the investigation and analysis, the actual root cause could not be identified, thus no corrective/preventive action will be taken at present.The possible cause is improper insertion utilized during end user operation and it was not related to the manufacturing process.This complaint will be used for trending purpose.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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; 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: 6590983
• MDR Text Key: 75962643
• Report Number: 3011410703-2017-00219
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 461243
• Device Catalogue Number: 461243
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other