MAUDE Adverse Event Report: DEPUY MITEK FMS VUE FLUID MANAGEMENT SYSTEM; FMS EQUIPMENT SYSTEMS

Catalog Number 284002

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure, delayed (2565)

Event Date 11/19/2014

Event Type  Injury  

Event Description

It was reported by the sales rep the fms vue was being used in a rotator cuff procedure with a patient that had heavy bleeding and reported there were inflow and outflow issues, where air bubbles were getting into the cavity during the procedure, as well as cannula suction issues when the doctor tried using her scope with the fms vue.External suction was used to allow proper suction of the fluid from the cavity.The case was completed using the same unit with no consequence to the patient.One fms vue will be returned for analysis by the customer.The tubing set was discarded.Additional information received by mitek complaint on (b)(6) 2014: the sales rep reported a delay over 30 minutes in the procedure.

Manufacturer Narrative

The unit was evaluated and the reason for return : " inflow and outflow issues" could not be duplicated.The unit passed all diagnostic tests, functional tests, and is fully operational.Further, a review into the depuy mitek complaints system did not reveal any other previous complaints reported on this device.Based on the information provided, a root cause for the failure cannot be discerned.At this point, no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: FMS VUE FLUID MANAGEMENT SYSTEM
• Type of Device: FMS EQUIPMENT SYSTEMS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4306002
• MDR Text Key: 17291711
• Report Number: 1221934-2014-00545
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2014
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other