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

Catalog Number 284002

Device Problem Suction Failure (4039)

Patient Problem Not Applicable (3189)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).(b)(6).Investigation summary: the device was sent to the service center for evaluation.The repair reports indicate: neither the fault reported by the customer could be verified nor another fault was found.Functional test acc.To test procedure completed.The input report indicates that there are scratches on the cover.The cover was not replaced.We cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.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 9-12-2017 and passed all functional testing before being returned to the customer.No further investigation is required.No further investigation is required.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.

Event Description

It was reported by the affiliate in (b)(6) that during a mid-shoulder arthroscopy, it was observed that the outflow pump was not working on the fms vue pump device.There was an unspecified delay in the surgery; however, it was reported that the surgery was completed.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8577602
• MDR Text Key: 143959805
• Report Number: 1221934-2019-56985
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• UDI-Public: 10886705020591
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/15/2019
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1