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

Model Number REDEUCE PUMP TUBING W/CONN, 8' LONG

Device Problem Defective Device (2588)

Patient Problems Pain (1994); Swelling (2091); Vascular System (Circulation), Impaired (2572)

Event Date 07/23/2020

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 that during an acl reconstruction procedure, that took place (b)(6) 2020, the patient developed compartment syndrome. The surgeon noticed the issue when putting the dressings on the patient while still in the procedure room. The surgeon used gravity and massage in attempts to remove the fluid but then had to perform a fasciotomy. This was done while still in the procedure room, immediately after the acl reconstruction had been completed. The patient had not yet left the room. The patient was kept overnight due to the issue. The wounds were closed on (b)(6) 2020 and the patient is scheduled to be discharged on (b)(6) 2020. The pump did not alarm during use and seemed to perform normally. The surgeon requested the pressure be increased several times during the procedure. The pressure started at 35 and ended at 60. There was no fluid coming out of the portals. The following tubings were used with the pump: ar-6411 (lot 40060968) and ar-6421 (lot 40067186).

• Brand Name: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Type of Device: ARTHROSCOPE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 10379287
• MDR Text Key: 202080331
• Report Number: 1220246-2020-02015
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6411
• Device Lot Number: 40060968
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/07/2020 Patient Sequence Number: 1