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

Catalog Number 284002

Device Problems Unknown (for use when the device problem is not known) (2204); Insufficient Information (3190)

Patient Problem Extravasation (1842)

Event Date 03/03/2015

Event Type  Injury  

Event Description

While using the pumps (both pumps software version 3.08) by both patients, the visibility on monitor is low; after operation, the shoulders of both patients were inflated.Additional information from the affiliate: yes, these were two procedures, i can confirm that.Here are the answers to your questions for (b)(4), dr.(b)(6): bankart surgery; not more than 30 min; did the patient have to stay in hospital longer - unknown.Did the surgeon do anything for the swelling - unknown.Procedure was as planned, no changes.Second complaint file under medwatch 1221934-2015-00667.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Device awaiting return.

Manufacturer Narrative

The complaint device is not being returned, therefore unavailable for a physical evaluation.The reported condition could not be confirmed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.If new information or device is returned for evaluation, this file will be reopened and updated to reflect changes.

Event Description

While using the pumps (both pumps software version 3.08) by both patients the visibility on monitor is low, after operation the shoulders of both patients were inflated.Additional information from the affiliate: yes, these were two procedure i can confirm that.Here are the answers to your questions for (b)(4), dr.(b)(6): bankart surgery.Not more than 30 min.Did the patient have to stay in hospital longer - unknown.Did the surgeon do anything for the swelling - unknown.Procedure was as planned no changes.Second complaint file under medwatch 1221934-2015-00667.

• 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: eric so ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4639083
• MDR Text Key: 19724114
• Report Number: 1221934-2015-00666
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor,company repres
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2015
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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