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 Date 05/11/2016

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 complaint device is not being returned for evaluation.The sales rep troubleshot the pump and determined there was no problem with the device; rather the error code was caused by it was not in the right mode "duo".The sales rep tested the pump and returned it to service where it has been used for the last year without an issue.A review into the depuy synthes mitek complaints system revealed two other dissimilar complaints for this device's serial number.No corrective action is required and no further action is warranted at this time.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.Dhr review: part number: 284002; supplier lot number: f10a20839; qty of lot: 12.Release to warehouse date: 3/30/2015.Manufacturing date: 3/1/2015.Supplier: (b)(4).Manufacturing site: (b)(4).Any anomalies or discrepancies in the manufacture of the lot: no.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.(b)(4).

Event Description

It was reported that the outflow part of the pump was not working during a shoulder decompression procedure.It was not sucking and the door appeared to have a disconnect with the tubing.There was a five minute delay swapping out the pump and no patient consequence.

Manufacturer Narrative

Epuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) a review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.

• 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
• MDR Report Key: 8281850
• MDR Text Key: 135532397
• Report Number: 1221934-2019-56159
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• UDI-Public: 10886705020591
• Combination Product (y/n): N
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2019
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1