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

Catalog Number 284002

Device Problem Insufficient Information (3190)

Patient Problem Edema (1820)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

The unit was evaluated and no functional fault was found.The unit passed all diagnostic tests, functional tests, and is fully operational.Cosmetic repairs were performed on defective parts.Repairs and software upgrades were made per service bulletins.A root cause for the reported failure cannot be discerned.The complaint device cannot be determined to be the root cause of the reported issue.Further, a review into the depuy mitek complaints system revealed three unrelated and non reportable complaints for this serial number in the past.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.

Event Description

Fms pump - surgery was interrupted on (b)(6) 2015 by 45 minutes due to a faulty pump.After surgeon did lateral release patient's knee began filling with fluid- 45 minute delay.Finished procedure by turning off pump and drained the knee until swelling went down then was able to close up knee up and patient able to go home.No patient harm or consequence.

• Brand Name: FMS VUE FLUID MANAGEMENT SYSTEM
• Type of Device: FMS PUMP
• 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: 5415540
• MDR Text Key: 37611569
• Report Number: 1221934-2016-10021
• 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
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2016
• Date Manufacturer Received: 01/08/2016
• 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: N
• Patient Sequence Number: 1
• Patient Age: 45 YR