MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 07/18/2019

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 halfway through a knee arthroscopy, the pump started running at a much higher rate than indicated and never achieved the desired pressure on the display.The pump was set on 35 and there was no alarm when this was occurring.The case was stopped due to the excessive fluid and the patient developed compartment syndrome.An additional incision was made as a fasciotomy was performed to reduce the pressure.The case was aborted and the procedure will be rescheduled.The rep noted the reservoir was halfway full of fluid before the case started.He warned the tubing needed to be set up again but the nurse stated it was set up correctly as it always has in the past.The doctor went on to start the case despite the warning.Pump setting was 35.The planned procedure was a knee arthroscopy chondroplasty and possible oats.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• 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: 8864643
• MDR Text Key: 153397882
• Report Number: 1220246-2019-01232
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• 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: Other
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• 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: 10081685
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other