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U.S. Department of Health and Human Services

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

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ARTHREX, INC. DUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHROSCOPE Back to Search Results
Catalog Number AR-6480
Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913); Pumping Problem (3016)
Patient Problem No Code Available (3191)
Event Date 09/11/2016
Event Type  Injury  
Manufacturer Narrative
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. Device history record review revealed nothing relevant to this event. 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 yet returned to arthrex. Additional information has been requested but not made available. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. 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 the device is returned and additional information is obtained, a follow-up report will be submitted. Device expected but not yet returned.
 
Event Description
It was reported that during a knee arthroscopy on (b)(6) 2016 the suction did not work, the tubing was then changed and a new ar-6430 was installed. Suction did not work and pump did not stop pumping. Per reporter, there was high pressure in patient´s knee joint. Complete arthroscopy tower (active devices) has been changed and surgery was finished with another pump and tubing combination. It was reported that when patient was uncovered it was recognized that fluid was pumped into patient´s thigh and also into his groin area. A blood-arrest was placed on patient´s thigh during surgery. Per surgeon the patient is fine and will not have any further subsequential injury. Follow-up investigation: patient had to stay in clinic 2 nights more than planned, no further info available.
 
Manufacturer Narrative
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. This is a follow-up submission to reflect device evaluation. Device history record review revealed nothing relevant to this event. Complaint not confirmed. The evaluation did not reveal anything relevant to the event. The returned ar-6480 was function tested with new tubing sets (ar-6410 & ar-6430) at varying pressure settings and no abnormalities were observed. 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 the device is returned and additional information is obtained, a follow-up report will be submitted.
 
Event Description
It was reported that during a knee arthroscopy on (b)(6) 2016 the suction did not work, the tubing was then changed and a new ar-6430 was installed. Suction did not work and pump did not stop pumping. Per reporter, there was high pressure in patient´s knee joint. Complete arthroscopy tower (active devices) has been changed and surgery was finished with another pump and tubing combination. It was reported that when patient was uncovered it was recognized that fluid was pumped into patient´s thigh and also into his groin area. A blood-arrest was placed on patient´s thigh during surgery. Per surgeon the patient is fine and will not have any further subsequential injury. Follow-up investigation: patient had to stay in clinic 2 nights more than planned, no further info available.
 
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Brand NameDUALWAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
Type of DeviceARTHROSCOPE
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 Key6022083
MDR Text Key57158717
Report Number1220246-2016-00416
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAR-6480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
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: 10/12/2016 Patient Sequence Number: 1
Treatment
AR-6430, DW CASSETTE TUBE SET, LOT UNKNOWN
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