MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 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 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by the customer via phone that the fms vue pump was not working as it was not sucking in water.The case was completed by using another like device without any patient harm or surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy 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.The device was received and evaluated at the service center.Per operational and diagnostic analysis confirmed reported issue (not sucking in water), worn fingers on pressure arm housing is causing the issue.Also found suction follower arm is locking up and console cover is damaged.However, the repair and testing of the unit will not be completed at the time because there is no need for it in the equipment loaner pool due to excess units in it at the time.Unit placed into long term hold.The worn fingers are caused due to the usage of the device over time.However, given the information provided we cannot discern a definitive root cause for the locked follower arm and damaged cover.A manufacturing record evaluation was performed for the finished device (serial number : d34a20103), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.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.Udi: (b)(4).

• Brand Name: FMS VUE PUMP
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8727595
• MDR Text Key: 149269623
• Report Number: 1221934-2019-57404
• 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
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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: 06/22/2019
• Date Manufacturer Received: 07/26/2019
• Patient Sequence Number: 1