MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Catalog Number 284002

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The defect reported has been verified and repaired.Performed service and repair functions.Reviewed service history.Attach box label, software upgrade form, and fms vue final testing.Replaced springs on pressure arms with tip replacement kit to correct issue.Also replaced damage console cover, front bezel and membrane switch, and left side door assy.Performed software upgrade to the latest versions.The unit passed all diagnostic tests, functional tests, and is fully operational.Details can be found in the attached reports.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.A review into the depuy synthes mitek complaints system revealed no other complaints for this device's serial number.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.(b)(4).This report is being filed from the (b)(4).Complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the customer that during a shoulder procedure, it was observed that the pump pressure rose up to 120 and went down to low pressure.The day set was replaced but the problem persisted.It was unknown how the procedure was completed and there were no patient consequences nor delays in the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: FMS VUE PUMP
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7955867
• MDR Text Key: 123505264
• Report Number: 1221934-2018-54921
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• UDI-Public: 10886705020591
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2015
• Date Manufacturer Received: 10/29/2015
• Date Device Manufactured: 07/01/2014
• 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