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 06/17/2019

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 sales rep via phone that the outflow function of the fms vue pump was not working properly which is causing the loss of more saline than normal.They were able to complete the case with another like device with no surgical delay or no patient harm.This is all the information the sales rep has at this time.

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.

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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received at the service center.The customer reported an issue of outflow was not working properly, per service manual operational and diagnostic analysis did not confirm the reported issue, therefore this complaint cannot be confirmed.The repair and testing of the unit will not be completed at this time because there is no need for it in the loaner equipment pool due to excess units in the pool at this time.Unit placed into long term hold.As no defect was identified, a root cause for the issue that was experienced by the user cannot be determined.A manufacturing record evaluation was performed for the finished device serial number, and no non-conformances related to the reported complaint condition were identified.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.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: 8794414
• MDR Text Key: 151174013
• Report Number: 1221934-2019-57677
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/01/2019
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 07/25/2019; 08/02/2019
• Supplement Dates FDA Received: 07/30/2019; 08/07/2019
• Patient Sequence Number: 1