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

Catalog Number 284002

Device Problem Insufficient Information (3190)

Patient Problem Extravasation (1842)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

Additional 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 that during an arthroscopic procedure, the fms vue was not keeping the surgeon's vision clear and caused extravasation.The sales rep reported the extravasation was noticable but was able to be treated with compression.The patient was able to go home as scheduled with no adverse consequences.The surgeon completed the procedure with the same pump.There was a 5 minute delay reported in the procedure.

Manufacturer Narrative

Performed service and repair functions as per (b)(4).Reviewed service history.Attach box label and fms vue final testing, software upgrade was not needed.Replaced irrigation's pump roller head ( loud clicking noises).The unit passed all diagnostic tests, functional tests, and is fully operational.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.

• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5452131
• MDR Text Key: 38744340
• Report Number: 1221934-2016-10040
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2016
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2016
• 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