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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. REDEUCE PUMP TUBING W/CONN, 8' LONG ARTHROSCOPE

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ARTHREX, INC. REDEUCE PUMP TUBING W/CONN, 8' LONG ARTHROSCOPE Back to Search Results
Model Number REDEUCE PUMP TUBING W/CONN, 8' LONG
Device Problem Defective Device (2588)
Patient Problems Pain (1994); Swelling (2091); Vascular System (Circulation), Impaired (2572)
Event Date 07/23/2020
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported that during an acl reconstruction procedure, that took place (b)(6) 2020, the patient developed compartment syndrome. The surgeon noticed the issue when putting the dressings on the patient while still in the procedure room. The surgeon used gravity and massage in attempts to remove the fluid but then had to perform a fasciotomy. This was done while still in the procedure room, immediately after the acl reconstruction had been completed. The patient had not yet left the room. The patient was kept overnight due to the issue. The wounds were closed on (b)(6) 2020 and the patient is scheduled to be discharged on (b)(6) 2020. The pump did not alarm during use and seemed to perform normally. The surgeon requested the pressure be increased several times during the procedure. The pressure started at 35 and ended at 60. There was no fluid coming out of the portals. The following tubings were used with the pump: ar-6411 (lot 40060968) and ar-6421 (lot 40067186).
 
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Brand NameREDEUCE PUMP TUBING W/CONN, 8' LONG
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
8009337001
MDR Report Key10379287
MDR Text Key202080331
Report Number1220246-2020-02015
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberREDEUCE PUMP TUBING W/CONN, 8' LONG
Device Catalogue NumberAR-6411
Device Lot Number40060968
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2020 Patient Sequence Number: 1
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