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

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.

• Brand Name: PUMP, CONTINUOUS WAVE II
• 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: 6063762
• MDR Text Key: 58658207
• Report Number: 1220246-2016-00429
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K919721
• Number of Events Reported: 1
• 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 Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-6400
• Device Lot Number: 4351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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
• Treatment: AR-6411, REDEUCE PUMP TUBING, LOT 14690.
• Patient Outcome(s): Other
• Patient Age: 57 YR