MAUDE Adverse Event Report: ARTHREX, INC. DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE; ARTHROSCOPE

Catalog Number AR-6480

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Per the event description, the rep stated that the nurse noted that while prepping for the case and prior to the rep being present in the room, the surgeon spiked the saline bags before connecting sensor to pump.Based on the information provided, the most likely cause(s) of this type of event is or procedures related to the set-up of the device and tubing did not conform to instructions provided or by the end user disconnecting and reconnecting the tubing from the pump or spiking the saline bags in the incorrect order.The labeling for the device and associated tubing, instruction manual for the pump and troubleshooting guide for the device clearly outline the proper set-up procedure and sufficiently warn the user of the potential consequences (extravasation) if instructions for use are not followed.The instructions for use for both the pump and tubing sets clearly warn the user of the consequences of not following the instructions for use.On the tubing package, there is a label instructing the user as follows: warning: do not reconnect tubing for any reason.Reconnecting tubing that was disconnected may cause pump pressure monitoring system errors which may cause extravasation that could result in serious patient injury.This is the first complaint of this type for this part/serial number combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device expected but not yet returned.

Event Description

It was reported that while performing an acl repair, the surgeon noticed that the leg of the patient had become greatly enlarged and visually hard.The swelling extended down to the calf and up into the thigh.At that point the tourniquet was turned down and the pump was turned off.The swelling in patient's leg started to reduce and the surgeon confirmed that the tissue was slightly softer.The surgeon decided to abort the case 16 minutes after starting and a vascular surgeon was called in.The surgeon confirmed a strong pulse in the ankle of the patient.The surgeon stated that the patient's joint was extremely tight.Pump setting was 60.Tubing chamber was filled with fluid to normal levels.The rep stated that the nurse noted that while prepping for the case and prior to the rep being present in the room; the surgeon spiked the saline bags before connecting sensor to pump.

• Brand Name: DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
• 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, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337017
• MDR Report Key: 5681363
• MDR Text Key: 45964436
• Report Number: 1220246-2016-00238
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/05/2016

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 Catalogue Number: AR-6480
• Device Lot Number: NX2253PG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other