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

Model Number 6661

Device Problems Fluid/Blood Leak (1250); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 05/29/2013

Event Type  malfunction  

Event Description

The customer reported a pressure dome leak.Name of complainant: same as reporter.Customer called to report return pressure dome leak during recirculation/return phase of the treatment procedure, right before photoactivation.Customer stated that return was taking place when she observed fluid leaking from the return pressure dome.Customer at this point stopped the procedure to abort it and did not return any products to the patient.Cts asked if there were any alarms during prime, customer stated there were no alarms during prime or throughout the entire procedure.Customer stated that upon closer inspection of the return pressure dome, she could see that the diaphragm was not on all the way.Service order# (b)(4) was dispatched for inspection of the instrument.The customer submitted photos for investigation.

Manufacturer Narrative

A review of lot history file for a121 shows (b)(4) for exceeding bioburden alert limit.There were no alarms associated with this event type noted for this lot.This lot met all release requirements.A review of complaints received for lot a121 was performed.There were (b)(4) other complaints for pressure dome leaks to date for this lot.No trends detected.Service order# (b)(4) feedback: field engineer verified that the pressure sensors are clean and working ok.Calibrated the pressure sensors.Performed a system checkout procedure and no issues were found.All pressure sensors are functioning.Instrument is operating as expected.No physical part was received for analysis.The customer provided a photograph to document the leak.The analysis was conducted solely on review of the photograph.Based upon review of the photo, the analysis is inconclusive.Without the return to examine, a positive assessment of root cause cannot be made.A more thorough analysis could have been performed if the kit had been returned.Based on the analysis for this complaint no remedial action was taken.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).Refer to capa# (b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM.
• Type of Device: CELLEX ECP SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east suite 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3767100
• MDR Text Key: 4552824
• Report Number: 2523595-2013-00240
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2012
• Device Model Number: 6661
• Device Lot Number: A121-KIT
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2013
• Initial Date FDA Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 58