MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number C149 - KIT

Device Problems Device Alarm System (1012); High Test Results (2457); Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

Customer called to report that return line air detector had not detected the air in the tubing at the end of the procedure.Return bag was already empty.Customer reported the return air sensor did not alarm when air passed through the sensor during the last re-infusion of cells after photoactivation and the pumps on the machine did not stop.Customer also reported that the volume in the return bag was higher than usual both visually and on the screen.Service was dispatched ((b)(4)).The replaced air detector is being returned for investigation.Customer stated they will send the smart card for investigation but it has not yet been received at the time of this report.

Manufacturer Narrative

A review of lot c149 was performed and there were no non-conformance for this lot.This lot met all release requirements.Trends were reviewed for all complaint categories and a downward trend was detected for equipment performance (air not detected).This is a known type of complaint in the risk file.Therakos continually works to reduce this occurrence as far as possible.However, air detected events are known to occur at avery low level.Furthermore, the air detector is designed to allow small bubbles to pass through without alarm, as these bubbles can occur during treatment and do not pose a safety risk to the patient.Service order (b)(4) feedback: the alarm was found to be functional.No fault was found.The field engineer replaced the air detector per the customer's request.Field engineer to send replaced air detector for investigation.The product return investigation is still in progress at the time of this report.A supplemental report will be filed when this investigation is complete.(b)(4).

Manufacturer Narrative

The customer complaint states that the return line air detector had not detected the air in the tubing at the end of the procedure.According to the complaint, prior to the operator stopping the procedure, the air in the return line had moved to 2-3 cm after the return line pressure dome.During the procedure, the air detector is continuously monitored via embedded software to ensure it is functioning correctly.The air detector requires a 125ul bubble, which would be about 2cm in length, to sense air in the line, and trigger the air detected alarm.Given this fact, and the system response time of approximately 1 second to stop the pump and close the occlusion clamp, an air bubble may move slightly (2-3 cm) past the detector head as described in the complaint.The air detector system continuously performs a self-test every 2 seconds during treatment to ensure that the safety systems are performing as expected.If the periodic test were to sense an air detector failure mode, a system error would be generated which prevents blood movement by stopping the pumps and occluding all flow paths to the patient while sounding an alarm which may only be reset via a power cycle.Therakos cannot confirm whether the air bubble was continuous or if there was a small amount of air mixed in with fluid.It is difficult to visually determine if there is air mixed with liquid.The air detector system is designed to allow micro-bubbles less than 125 microliters in size to pass through the air detector without generating an air detected alarm.Per the service order feedback, the alarm was found to be functional.No fault was found.The field engineer replaced the air detector per the customer's request.Furthermore, the air detector was returned for evaluation.It was found to be functioning correctly when challenged per manufacturing testing specifications.This is an indication that the system was working as designed.Finally, trends were also reviewed for the reported issues, and no trend was detected for air detector failures, air not detected, or air detected alarm failures.These failures are identified in the risk file, and therakos continually works to reduce them as far as possible.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4623955
• MDR Text Key: 5574191
• Report Number: 2523595-2015-00076
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Lot Number: C149 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 77