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

Catalog Number 284002

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). Investigation summary: performed service and repair functions. Reviewed service history. Attached box label, software upgrade form, and fms vue final testing. The unit was evaluated and no functional fault was found. Performed software upgrade to the latest versions. Replaced springs on pressure arm housing (preventive maintenance) with tip replacement kit. The unit passed all diagnostic tests, functional tests, and is fully operational. A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the sales rep that during an unspecified surgical procedure, it was observed that the fms vue pump device had no suction; and that the toggle was not working. There was no delay in the surgical procedure as an identical spare device was used to complete 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8284744
• MDR Text Key: 134334396
• Report Number: 1221934-2019-56198
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/23/2017
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown