MAUDE Adverse Event Report: ARTHREX, INC. DW OUTFLOW CASSETTE/TUBE SET; K083707

Model Number DW OUTFLOW CASSETTE/TUBE SET

Device Problems Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

Patient Problems Muscular Rigidity (1968); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/18/2020

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 facility risk manager, that a patient was undergoing a scheduled outpatient procedure for a left knee arthroscopy, lateral meniscus debridement vs.Repair.The procedure was taking place (b)(6) 2020.During the procedure the arthrex ar-6480 dual wave arthroscopy pump, serial number (b)(4), exhibited an abnormal sound.Described as a loud grinding noise.Immediate review of the pump showed no alarms and appropriate setup.Arthrex sales rep who was present immediately went to check the device and he removed one of the connected tubings and re-installed.At that point it was determined that the pump was producing excess fluid.The stopcock was opened and excess fluid arched out and the fluid hit a staff member in the head.At this point it was discovered that the patient¿s thigh was rigid and compartment syndrome was diagnosed.The surgery was stopped and the procedure was aborted.Once the issue occurred the arthrex rep contacted the arthrex territory manager who also joined the room the patient required a left thigh fasciotomy with wound vac placement (for compartment syndrome) in the left thigh above the incision.Patient was admitted and underwent subsequent irrigation and drainage of the wound on (b)(6) 2020.Patient was discharged to home (b)(6) 2020 with wound vac.Once the issue occurred the arthrex rep contacted the arthrex territory manager who also joined the room.The following tubings were being used with the pump at the time of incident: ar-6410, arthroscopy pump tubing (lot 40067369) and ar-6430 dual wave outflow tube set (lot 40067372.At this time the patient¿s father has indicated reservations with regard to rescheduling the procedure and no second surgery date has been set.

• Brand Name: DW OUTFLOW CASSETTE/TUBE SET
• Type of Device: K083707
• 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: 10934653
• MDR Text Key: 219172390
• Report Number: 1220246-2020-02387
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039322
• UDI-Public: 00888867039322
• 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: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DW OUTFLOW CASSETTE/TUBE SET
• Device Catalogue Number: AR-6430
• Device Lot Number: 40067372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 98