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

Catalog Number 284002

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure aborted/stopped (2563)

Event Date 03/31/2015

Event Type  Injury  

Event Description

It was reported by the customer ¿resident said inflow on fms pump was weak; the pressure was raised.He said it was still week.I hit the run/stop button and it wouldn¿t come off of standby.I hit the fill button and the pressure chamber filled almost completely.The staff and two nurses and tech were called came in to help.New outflow tubing was added and connected to the field and pump.The pump would not come off of solo.The pump kept running.The resident noticed the saline and epi was injected into the patient¿s thigh.The staff decided to abort the case.¿.

Manufacturer Narrative

The unit was evaluated and the reasons for return could not be duplicated.The unit passed all diagnostic tests, functional tests, and is fully operational.Sales rep investigated the pump and provided the following information: on first inspection of the pump it was noticed the setup was not done properly.The inflow pressure chamber was completely filled with fluid resulting in the pressure sensor becoming wet.We were informed that the two nurses who set it up were not ortho nurses but neuro nurses, and do not work with arthroscopic pumps often.The nurse could not verify that the connection with the tubing and pressure sensor connector was complete.In-conclusion, it was believed this situation was the result of improper setup and not equipment malfunction.The connection wasn't complete between the pressure chamber tubing and cpu connector along with improper filling of the pressure chamber.An in-service meeting has been set up for the staff to go over the setup, functions, and any questions that people may have.Further, a review into the depuy mitek complaints system revealed no other 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.

• Brand Name: FMS VUE FLUID MANAGEMENT SYSTEM
• Type of Device: FMS EQUIPMENT SYSTEMS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4738498
• MDR Text Key: 5824800
• Report Number: 1221934-2015-00731
• 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: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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: 04/21/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/31/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2015
• Date Manufacturer Received: 04/03/2015
• 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