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 Extravasation (1842)

Event Date 09/09/2014

Event Type  Injury  

Event Description

It was reported by the sales rep that during a rotator cuff repair the pump was not controlling the pressure correctly and caused slight extravasation of the shoulder, was not controlling the bleeding correctly or extending the joint properly.Customer also stated that too much saline had to be used.Customer was able to complete the procedure using the pump.No patient consequences.Device to be returned.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In process.

Manufacturer Narrative

The customer¿s complaint could not be duplicated and no fault was found on this pump.The device passed all tests.Furthermore, there were no other complaints reported on this serial number.At this point in time, no further action is warranted.However, depuy (b)(4) 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

It was reported by the sales rep that during a rotator cuff repair the pump was not controlling the pressure correctly and caused slight extravasation of the shoulder, was not controlling the bleeding correctly or extending the joint properly.Customer also stated that too much saline had to be used.Customer was able to complete the procedure using the pump.No patient consequences.Device to be returned.

• 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: 4116339
• MDR Text Key: 16852061
• Report Number: 1221934-2014-00419
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130170
• 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,Followup
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2014
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other