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

Catalog Number 284002

Device Problem Insufficient Information (3190)

Patient Problem Abdominal Distention (2601)

Event Date 09/10/2015

Event Type  Injury  

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.Awaiting return.

Event Description

It was reported by the sales rep that they were getting a lot of distention during use.No additional information was known.Additional information received via phone by mitek complaints on 09/10/2015: the sales rep reported that during a shoulder procedure that the fms vue pump was not functioning correctly and caused extravasation in the shoulder area.He reported that the visibility was reduced causing the procedure to be extended by 15 minutes.The sales rep reported that the area was manually decompressed to reduce the fluid buildup but that the patient was fine post-op and allowed to go home as planned.

Manufacturer Narrative

The pump was received at the repair center and tested.The pump failed the occlusive test.The springs on pressure arm housings and the plungers were replaced to correct issue.The root cause of this failure is a worn spring and plunger.The unit passed all diagnostic tests, functional tests, and is fully operational.This complaint can be confirmed.A review into the depuy mitek complaints system revealed no other complaints of any type for the serial number of this device.At this point in time, no further action is warranted.However, 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

It was reported by the sales rep that they were getting a lot of distention during use.No additional information was known.Additional information received via phone by mitek complaints on 9-10-15: the sales rep reported that during a shoulder procedure that the fms vue pump was not functioning correctly and caused extravasation in the shoulder area.He reported that the visibility was reduced causing the procedure to be extended by 15 minutes.The sales rep reported that the area was manually decompressed to reduce the fluid buildup but that the patient was fine post-op and allowed to go home as planned.

• 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: eric so ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 5142311
• MDR Text Key: 28023930
• Report Number: 1221934-2015-01003
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• 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; Required Intervention