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

Catalog Number 284002

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/13/2016

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).Awaiting device return.

Event Description

Fms vue pump kept powering on and off during procedure.No patient harm.Delay more than 30 minutes.Surgery type unknown.

Manufacturer Narrative

The complaint device was returned to our service center and an evaluation was performed.The unit was evaluated and the reason for return: "kept powering on and off" could not be duplicated.The unit passed all diagnostic tests, functional tests, and is fully operational.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this device that was manufactured in the first week of july, 2013.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.Udi: (b)(4).

• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5417467
• MDR Text Key: 37714112
• Report Number: 1221934-2016-10023
• 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: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• 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
• Device Age: 31 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2016
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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 Outcome(s): Other