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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. PUMP, CONTINUOUS WAVE II ARTHROSCOPE

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ARTHREX, INC. PUMP, CONTINUOUS WAVE II ARTHROSCOPE Back to Search Results
Catalog Number AR-6400
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Chest Pain (1776); Dyspnea (1816); Swelling (2091); Coma (2417); Ambulation Difficulties (2544)
Event Date 01/15/2016
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 returned to arthrex. Additional information has been requested but not made available. This is the first complaint of this kind for this part/serial number combination. Facility will not release the device.
 
Event Description
It was originally reported that a redeuce pump tubing set was used in a continuous wave ii pump for a shoulder arthroscopy procedure. The pump dispensed fluid at a faster rate than expected near the end of the procedure. The patient's shoulder began to swell. The pump was shut down and the tubing was replaced. The procedure was able to be completed. Follow-up investigation: patient was intubated and sedated after the (b)(6) 2016 event and was transferred to icu. When awakened patient had difficulty breathing or talking, was coughing and unable to move. A thoracentesis was performed in the icu. Patient received physical therapy to steady walking and regain some balance prior to discharge from hospital on (b)(6) 2016. Patient was weak and needed assistance to get out of bed and used a cane to steady herself at time of discharge. Patient continued to have breathing issues and chest pains and headaches. Patient symptoms were largely resolved in approximately 3 months with very occasional symptoms.
 
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Brand NamePUMP, CONTINUOUS WAVE II
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 Key6063762
MDR Text Key58658207
Report Number1220246-2016-00429
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K919721
Number of Events Reported1
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 10/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAR-6400
Device Lot Number4351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2015
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: 10/28/2016 Patient Sequence Number: 1
Treatment
AR-6411, REDEUCE PUMP TUBING, LOT 14690.
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