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

Model Number 284002

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the inflow side of the device was not pumping water into the shoulder and magnets in door were not connecting properly.Per service report, the reported faults were duplicated, therefore this complaint can be confirmed.Both ils door sensors and left & right door assemblies were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The defective door sensors and door assemblies are responsible for the reported problems.With the available information, we cannot determine how these components became defective.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 07/19/2019 and passed all functional testing before being returned to the customer.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).

Event Description

Case 2: it was reported by affiliate via email, that during a shoulder subacromial decompression, the inflow side of a fms vue fluid management system, was not pumping water into the shoulder.The ns tried trouble shooting by opening and closing the access window multiple times before the pump started to work correctly.Ns have reported that a similar occurrence has happened before, and they needed to place pressure on the door.Potentially magnets in door not connecting properly? ns generally very good at setting up the pump.No surgical delay or patient consequence reported.This additional case captured in regards to event description mentioned in (b)(4) as "ns have reported that a similar occurrence has happened before." additional information provided by the affiliate reported the case was completed with the same device.

• 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
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10623074
• MDR Text Key: 210234477
• Report Number: 1221934-2020-02860
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• UDI-Public: 10886705020591
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• 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: 05/19/2020
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1