MAUDE Adverse Event Report: ARTHREX, INC. CWIII ARTHROSCOPY PUMP; ARTHROSCOPE

Catalog Number AR-6475

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 10/14/2016

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.Complaint not confirmed.No problems found.The returned ar-6475 was run with lab tubing set at varying pressures.Pump ran for an approximate 20 mins with no issues.The returned ar-6410 tubing set was functioned tested with the returned ar-6475 pump.The tubing failed due to a collapsed bladder/sleeve.Device history record review revealed nothing relevant to this event.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.Also, incorrect pressure settings or inter-operative compromising of the joint capsule from other instrumentation could lead to such an event.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 knee arthroscopy procedure on (b)(6) 2016, the pump started to pump really fast.It immediately started to expand the knee.This occurred at the beginning of the case.The pump setting was 40.No alarms or error messages were received during use.A clamp test was performed.The tubing used with the pump was ar-6410, lot unknown.The same tubing was not connected, disconnected and reconnected.Once the excess fluid was noticed the tubing was changed to see if that was the issue.It was never re-applied to the joint.It was tested with the clamp and ran open into a bowl.The pump continued to run at a high rate.The pump was not used to complete the procedure.The surgeon removed the fluid from the patient's knee by performing a fasciotomy.The patient was kept overnight due to the excess fluid.The patient was discharged (b)(6) 2016.

• Brand Name: CWIII ARTHROSCOPY PUMP
• 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: 6159759
• MDR Text Key: 62081667
• Report Number: 1220246-2016-00556
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039346
• UDI-Public: 00888867039346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-6475
• Device Lot Number: NX2168MD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AR-6410 LOT UNKNOWN, MAIN PUMP TUBING
• Patient Outcome(s): Other