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Catalog Number AR-6410
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Cyanosis (1798); High Blood Pressure/ Hypertension (1908); Swelling (2091)
Event Date 11/30/2016
Event Type  Injury  
Manufacturer Narrative
Patient demographics (date of birth, 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. Device history record review revealed nothing relevant to this event. This is one of two submissions for the same patient event. The other is 1220246-2016-00570 (b)(4). The evaluation of the returned tubing revealed that the bladder/sleeve inside the drip chamber collapsed 100%. The ar-6480 pump was not returned for evaluation. Typically, this type of event is caused by the end user disconnecting and reconnecting the tubing from the pump or spiking the saline bags in the incorrect order. 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 the case was shoulder scope, arthroscopic distal clavicle resection and subpectoral tenodesis. During the case, the pump was accelerating, the inflow tube wheel was spinning at a high rate. It was set at 50 (standard setting). The canister was filling with water; it was about 2/3 full. Pressure was high; water was coming out of the cannula. The pump was turned off / on and the problem continued. They then changed out the tubing and the problem was solved. It was then seen that the patient arm from shoulder to elbow turned blue; blood pressure spiked; the swelling went up to the neck, down the back and into the stomach. They aborted the plan to do a arthroscopic distal clavicle resection. A sonogram was performed to check on lungs / vocal chords. Vitals were good; they did a subpectoral tenodesis as planned. The patient is being kept overnight. Patient (b)(6), (b)(6) years. Additional information obtained (b)(6) 2016: pump being used was ar-6480. Per reporter the pump has been checked by the facility's surgery maintenance and is deemed functional. If any additional incidence occurs the facility will return the pump at that time. Facility believes it was the pump tubing and have removed all additional tubing of the same lot out of their inventory. The surgeon provided an update to the reporter. Surgeon confirmed the patient is doing fine and patient went home the next day after the procedure. Surgeon has not gone back to do the patient's distal clavicle and does not have the patient rescheduled for any additional surgery.
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Manufacturer (Section D)
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath, sr. mdr analyst.
1370 creekside boulevard
naples, FL 34108-1945
MDR Report Key6190723
MDR Text Key62913600
Report Number1220246-2016-00571
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 12/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2021
Device Catalogue NumberAR-6410
Device Lot Number016376
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 Received11/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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: 12/20/2016 Patient Sequence Number: 1