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

Catalog Number AR-6480

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Joint Swelling (2356)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

This is one of two mfr. Reports for the same event. The other submission is referenced as 1220246-2016-00028. 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 received and an evaluation was conducted. The complaint was not confirmed. Device history record review revealed nothing relevant to this event. The original tubing set from the event was not returned for evaluation. The returned ar-6480 pump was run with lab tubing sets at varying pressures. Then the outflow tubing was clamped-off and as expected per the operations manual, the pump reported "over pressure" alarm. When the clamp was released, the pump returned to normal operation. Based on the information provided (and device evaluation), 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. 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. 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. In addition to equipment set-up, the operative joint capsule may have already been compromised from prior (pre-operative) injury or trauma. 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.

Event Description

It was reported that during a rotator cuff repair, right shoulder scr (superior capsular reconstruction), the shoulder became swollen during the procedure. Pump pressure was between 40-55 mm/hg. They switched pumps, but the same thing happened with the second pump. The case was completed but when they undraped the patient, they saw that fluid had migrated to the chest cavity and throat. The patient was intubated and flown to a hospital. No alarms were heard and the pumps seemed to work fine during the procedure. Tubing was discarded. It is unknown as to which pump was being used first.

• 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: 5414137
• MDR Text Key: 37611926
• Report Number: 1220246-2016-00027
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: AR-6480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 02/05/2016 Patient Sequence Number: 1