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

Model Number 383400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Not Applicable (3189)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer reports that during preventative maintenance of the pump, the pump was set at 125 ml/hour with an expected infused volume of 60.63 ml and 69.38 ml at a 30 minute test that is based on (b)(6) tolerance.The infused volume was 78 ml to 83 ml which is out of specification.

Manufacturer Narrative

To date, the unit has not been received for evaluation.Without the unit, a detailed investigation could not be performed and the reported condition could not be confirmed.This complaint file shall be closed as unconfirmed at this time.If the unit is returned, the complaint shall be re-opened.All device history records are reviewed for quality inspections and parameter.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: 6314674
• MDR Text Key: 67113378
• Report Number: 1282497-2017-05009
• 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: other,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: 01/23/2017
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: No
• 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