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

Catalog Number 284002

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Awaiting device return.

Event Description

Surgeon has problems with visibility due to bleeding.There was a perceived problem with the inflow and a problem with the outflow.Following a conversation with the scrub nurse during the case in question, (b)(6), it would appear the following has happened: there was a problem with the outflow due to a blockage with the rf wand.The rf wand was replaced and the outflow started working.Bleeding persisted causing poor visibility.Fms vue pressure was increased from 110 to 170 which helped but there were still visibility issues.At no point did the fms vue console alarm or show any error messages.It was agreed with the scrub nurse and senior theatre nurse that there was no issue with fms vue.It is probable that this particular patient had particularly bad bleeding which was difficult to control, thus causing poor visibility.The surgeon persisted with poor visibility to complete the procedure.The procedure was extended by one hour.There were no patient consequences reported.Additional information received by mitek complaint via email on 2-8-2016: the sales rep reported that he cannot get the product code and lot number of the wand and that the item was not our product anyway.The wand was an arthrocare wand.He also reported that the scrub tech and senior nurse confirmed that not having the manual did not exacerbate the situation.

Manufacturer Narrative

After re-reviewing the complaint, it was determined that the medwatch was filed in error and this event was determined not reportable since none of the mitek devices used were at fault.

• Brand Name: FMS VUE FLUID MANAGEMENT SYSTEM
• Type of Device: FMS PUMPS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: joseph cipollo ; 325 paramount drive; raynham, MA 02767 ; 5089773839
• MDR Report Key: 5477322
• MDR Text Key: 39597495
• Report Number: 1221934-2016-10063
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2016
• Date Manufacturer Received: 02/02/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other