MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Inflammation (1932)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that excessive fluid went into the patient leg resulting in a fasciotomy.The pump was set at 40 and never indicated any change.The acl was completed with the same pump.Patient was a (b)(6) male.

Manufacturer Narrative

The complaint was not confirmed.The returned pump was visually inspected and showed no physical damage to the unit.Further review of the pump sub-assembly and components showed no issues with the latch door or tubing connector.The tubing sets used were not returned.The pump was assembled with a new ar-6410 tubing, and then tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and function as intended with no error message and/or audible alarm triggered.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11947681
• MDR Text Key: 254805816
• Report Number: 1220246-2021-03227
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Device Lot Number: 21910038
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other