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

Catalog Number AR-6480

Device Problems Display or Visual Feedback Problem (1184); Output above Specifications (1432)

Patient Problems Overdose (1988); Swelling (2091)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

Maude report did not contain reporter contact information or facility/patient demographics.No additional adverse consequences have been reported from this event.This device is used for treatment.Serial number was not provided on the maude report.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.No follow up could be performed.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Unable to contact initial maude reporter.

Event Description

During a monthly maude review, it was discovered that a user facility had reported the following incident: during the arthroscopic diagnostic part of an acl reconstruction, the ar-6480 pump malfunctioned.The pump never displayed a change of pressure (was always between 30-35) but continued to run at a high speed for a very short time.All the fluid from two 3-liter bags went into the patient.The pump was stopped.The patient's leg became swollen and could not be flexed.Surgeon made the decision to abort the acl procedure.The incision was closed and dressing was applied.The patient was taken to pacu where her leg was still swollen but softer to touch.Patient was observed overnight and was then discharged home in stable condition.Per user facility policy, the device and tubing were sent for inspection.No initial user facility medwatch reporter contact information or facility information was available on the maude report.No follow up will be possible.

• 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: 5995138
• MDR Text Key: 56332844
• Report Number: 1220246-2016-00407
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• 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: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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