MAUDE Adverse Event Report: ARTHREX, INC. REDEUCE PUMP TUBING W/CONN, 8' LONG; ARTHROSCOPE AND ACCESSORIES

Model Number	REDEUCE PUMP TUBING W/CONN, 8' LONG
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/09/2024, it was reported by a sales representative via (b)(4) that an ar-6480 dualwave pump was acting up and pushing a ton of fluid into the patient's joint space.This occurred during a knee arthroscopy.The pump finally evened out and worked as usual.The fluid was more than usual in the knee post-op.Additional information was provided on 08/13/2024, where it was stated by the sales representative that this event occurred on 08/07/2024, and an ar-6410 tubing was used.The tubing was replaced, and there were no further issues.The patient did have fluid in the knee, and they just put dressings on and the knee fluid came down.The patient was discharged that day.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to unplugging and plugging the pressure line connector back into the arthroscopy pump, thereby creating a pressure decay on the pump and/or spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.

• Brand Name: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20124416
• Report Number: 1220246-2024-07332
• Device Sequence Number: 3152061
• Product Code: HRX
• UDI-Device Identifier: 00888867118027
• UDI-Public: 00888867118027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6411
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown