MAUDE Adverse Event Report: DEPUY MITEK FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE); FMS TUBING

Catalog Number 284508

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/04/2016

Event Type  Injury  

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.This type of failure has been typically observed when the tubing was not seated correctly on the rollers of the pump and the clamp is pressed down causing it to split.A batch record 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 (b)(4) complaints system revealed (b)(4) dissimilar 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 (b)(4) 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.(b)(4).

Event Description

The sales rep reported via phone that during a knee arthroscopy the tubing that goes to the pump on the customers fms vue irrigation tube set had a leak.The pressure chamber filled with water causing the device not to work.The sales rep states that the case was not able to be completed resulting in the surgeon having to do a fasciotomy due to pressure build up in the patients knee.The additional fasciotomy caused a 60 min delay in the procedure.The sales rep was not present during the time of the incident and the device was discarded.

• Brand Name: FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE)
• Type of Device: FMS TUBING
• 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: 6074547
• MDR Text Key: 59009310
• Report Number: 1221934-2016-10453
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 284508
• Device Lot Number: 931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2016
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other