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 Swelling (2091)

Event Date 02/20/2020

Event Type  Injury  

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.

Event Description

It was reported by the sales rep, that the resident was scoping the knee.The pump pressure was set at 50, as the case went on the pump reading stayed at 50 but was pushing fluid at a rate much higher.It was not noted what the flow rates were during the case, the surgeon said when he walked in the room he could hear the sound of the pump spinning trying to push fluid and noticed the joint and surrounding tissues had noticeably swelled.The case was completed successfully and the pt was monitored for any post op issues relating to the fluid absorption.Additional information obtained 03/12/2020: the surgeon opened a couple pockets in to the thigh compartment to release some fluid.The patient was not kept overnight but released approximately 6 hours after the completion of the procedure under supervision.

Manufacturer Narrative

The complaint was not confirmed.The returned ar-6480 was visually inspected and minor scratches on the top of the device.The returned ar-6480 device assembled with a new ar-6410 tubing was 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.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or; (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.These conditions can trigger the alarm for pressure fault.Final conclusions are potential misuse and the complaint allegation not confirmed.

• 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: 9910286
• MDR Text Key: 190965865
• Report Number: 1220246-2020-01770
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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: 10168797
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other