MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - RFB

Model Number 382401

Device Problems Inaccurate Delivery (2339); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 issue with an epump.The customer states the infusion was higher than usual.The incorrect delivery makes this complaint reportable.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of under/over deliver outside accurate limit.The unit was triaged and the customer¿s reported condition was confirmed.A trend has been identified and a capa has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO EPUMP - RFB
• Type of Device: EPUMP
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6219840
• MDR Text Key: 63953969
• Report Number: 3008361498-2017-00014
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

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: 382401
• Device Catalogue Number: 382401
• Device Lot Number: C0615389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: 07/27/2016
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1