MAUDE Adverse Event Report: DEPUY MITEK FMSFLUID MANAGEMENT SYSTEM/INFLOW TUBING; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Catalog Number 284504

Device Problem Pressure Problem (3012)

Patient Problem No Code Available (3191)

Event Date 12/01/2016

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).

Event Description

The sales rep reported via phone call that the customer's fms tubing- irrigation tube set failed during a shoulder arthroscopy procedure due to the pressure on the pump dropping from 40 to 30 and all the way down to 9 while the tubing was in the patient¿s joint causing the joint to fill up and be distended and swollen.The case was completed by resetting the pump and changing the tube set.This tubing was used with a dup pump.The rep stated the patients swelling was able to be slightly relieved by massaging the fluid out, some fluid came out.The rep stated that this was a set-up error.The rep was present for the case right before the issue started with the devices.There was adverse patient consequence due to the swelling of the joint and excess fluid in the shoulder.There was a 5 minute time delay reported.The tubing was discarded so it will not be returned for evaluation.No replacement per rep.

Manufacturer Narrative

The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.

Manufacturer Narrative

This follow up is being filed to correct the date to (b)(6) 2017.It was incorrectly reported on medwatch 1221934-2016-10576 follow up 1 as (b)(6) 2016.

• Brand Name: FMSFLUID MANAGEMENT SYSTEM/INFLOW TUBING
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6214223
• MDR Text Key: 63609749
• Report Number: 1221934-2016-10576
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951843
• 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,Followup
• Report Date: 12/01/2016,12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: 284504
• Device Lot Number: 1415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2016
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2015
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other