MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW

Model Number 382400

Device Problems Break (1069); Smoking (1585); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/03/2017.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 motor/rotor failed, the door was damaged, and unit was smoky.With the unit emitting smoke, this complaint is reportable.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of, the motor/rotor failed, and unit was smoky.The unit was triaged and the reported issue was confirmed.Previously an investigation was performed by r & d regarding the issue of gearboxes prematurely wearing, which can cause the gearbox to rotate in reverse and the graphite dust possibly giving off a smoky odor.Per the r & d study the most likely cause of this issue is due to the shaft material that was used.Enhancements have been implemented to prevent the reported condition from recurring.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Post market trending is in place to monitor for further occurrences.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: EPUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6219898
• MDR Text Key: 63953732
• Report Number: 3006451981-2017-00013
• 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: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Device Lot Number: C1366485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1