MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Model Number 284002

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Overfill (2404)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

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.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi: (b)(4).

Event Description

As reported by the sales rep via phone, the facility advised of an issue with the pump taking on water as they believe the fill chamber was not on tight.No reported delay in the case or patient consequence.This is all the information the sales rep was given.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.Investigation summary: the device was received and evaluated at the service center.The reported complaint that there was an issue with the pump taking on water was unable to be confirmed.No defects were found with the device upon evaluation.However the device was placed into long-term hold as it was not needed for the equipment exchange pool use.Since the reported condition is not confirmed, the root cause for the reported failure cannot be determined.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 06/11/2018 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.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): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10791750
• MDR Text Key: 214772812
• Report Number: 1221934-2020-03329
• 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
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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 Model Number: 284002
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2020
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/09/2020
• Removal/Correction Number: N/A
• Patient Sequence Number: 1