MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Model Number 284002

Device Problem Increase in Pressure (1491)

Patient Problem Not Applicable (3189)

Event Date 01/10/2020

Event Type  Injury  

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.(b)(6).Udi: (b)(4).

Event Description

It was reported by affiliate via phone that during a knee arthroscopy the fms vue pump needed a diagnostic test to be able to assess functionality.There was a 20 minutes surgical delay and also a patient consequence that caused fluid absorption in quadriceps.Also during the procedure the pump had to be change.The procedure was completed using an alternative product.No additional information was completed.

Manufacturer Narrative

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.It was reported that the unit fms vue pump needed a diagnostic test to be able to assess functionality.Per service manual operational and diagnostic, the reported failure was not confirmed.  during evaluation, the reported issue cannot be duplicated.Additionally, no other fault was found.The testing of the unit was completed per the service manual, the unit passed all functional tests and is fully operational.The possible root cause for the reported failure cannot be determined.  a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.  device history lot: a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

• 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: 9593020
• MDR Text Key: 185520026
• Report Number: 1221934-2020-00217
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 284002
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 02/12/2020
• Patient Sequence Number: 1