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

Catalog Number 284002

Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problems Extravasation (1842); Swelling (2091)

Event Date 11/01/2016

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

Fms vue pump not calibrated correctly, too much power, and way too much fluid, knee surgery too long due to inconsistency.No patient injury nor delay, hospital owned.The following additional information was received via phone by mitek complaints on (b)(6) 2016.The sales rep reported that towards the end of the case it was noticed that there was excessive fluid build up in the knee plus extravasation.The sales rep stated that the procedure was completed by gravity.

Manufacturer Narrative

The complaint device was returned to the mitek service center, and an evaluation was performed.The reported problem could not be confirmed.The complaint device passed all diagnostic and functional tests, and is fully operational.The complaint device console cover was replaced due to damage.A review of the complaint system revealed no other complaints of any kind for this device¿s serial number.We cannot discern a root cause for the reported failure mode; one possible root cause could be the pump was not set up properly, the location of the replacement device on the equipment tower has been lowered since this complaint event and the replacement device has not had any similar issues.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).

Event Description

The following additional information was received during follow-up with the sales rep via phone on 1-6-2017 while seeking clarification of information received earlier from the rep on 12-6-2016.: there were two complaints reported by the customer involving two different fms vue pumps.One of the procedures was a knee procedure that involved excessive fluid buildup in the knee area.One of the procedures was a shoulder procedure which involved excessive fluid buildup in the shoulder area.The customer was unable to identify which of the two pumps was involved in which of the two procedures.This complaint device was identified as being used in one of the two procedures.Both pumps were complaint devices.The sales rep stated that the pumps were fairly high on the tower at the time of the complaint events, and replacement devices have been moved to a lower location on the tower with no problems reported since.The sales rep stated that the shoulder procedure was a long procedure do to the nature of the repair, and a shaver was used without suction at times during the procedures.

• Brand Name: FMS VUE FLUID MANAGEMENT SYSTEMQ
• Type of Device: FMS PUMPS
• 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: 6159210
• MDR Text Key: 62082736
• Report Number: 1221934-2016-10540
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130169
• 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: 11/09/2016,01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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: 12/06/2016
• Is the Reporter a Health Professional?: No
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2016
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• 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