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 Codes	Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/5/2023, it was reported by a sales representative via sems-06021994 that an ar-6480 dw arthroscopy fluid management device had an issue.The surgeon noticed the pump's outflow was slow to respond, not pulling fluid fast enough.The patient was not affected.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.On 9/7/2023, the sales representative provided the following information via email and phone: this occurred during a shoulder arthroscopy procedure on (b)(6) 2023.An ar-6411 redeuce pump tubing and ar-6435 dualwave outflow tube set with redeuce tubing system with unknown lot numbers were used.The pump settings were at 45mmhg, and the pump was not keeping up with the pressure.Slight extravasation occurred, it was localized and a manageable issue.They used a rinse function w/ closed inflow portal to remove the excess fluid.The pump was used to complete the procedure successfully.The patient was discharged after the procedure and is fine to date, there was no harm reported and no case delay.The tubing sets were discarded after the procedure.
Additional 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.
Additional Manufacturer Narrative
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.Per dfu-0140-eo revision 0, h.Directions for use: warning: using fluid to distend any joint carries with it the possibility of fluid extravasation into surrounding tissue.Always use the lowest possible pressure settings to achieve the desired amount of distension and control of bleeding.Warning: proper operation of this device requires the establishment of adequate fluid outflow and monitoring of the surgical field.At pressures exceeding 10 mmhg above the patient¿s diastolic pressure, carefully monitor and maintain fluid outflow and assess the patient regularly to avoid extravasation or any other adverse patient condition.Warning: do not disconnect and reconnect the same tubing set under any circumstances.Once disconnected from the pump, the tubing set must be discarded and a new tubing set installed.Failure to do so may result in pump failure and patient injury.Failure to follow these instructions may pose a danger to the patient.Do not use the unit if the rollers turn continuously after the tubing has been clamped.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17862873
• Report Number: 1220246-2023-08054
• Device Sequence Number: 5909148
• Product Code: HRX
• UDI-Device Identifier: 00888867118027
• UDI-Public: 00888867118027
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/18/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/18/2024
• 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