MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Crack (1135); Leak/Splash (1354); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the photoactivation module leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f212 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f212 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #8: blood leak (photoactivation chamber) and photoactivation module leak.No trends were detected for these complaint categories.This assessment is based on information available at the time of the investigation.At the time of this report, we are still waiting on the kit and smartcard return.A supplemental report will be filed when the kit and smartcard have been received and the analysis of the kit, smartcard, and photos is complete.

Event Description

The customer e-mailed to report a photoactivation module leak and an alarm #8: blood leak (photoacativation chamber) alarm.The customer stated that towards the end of the treatment's photoactivation phase, there was "a loud noise from the photoactivation module".The customer reported that the alarm #8: blood leak (photoacativation chamber) alarm then occurred.The customer stated that there was a crack within the photoactivation module and a leak had occurred.The customer reported that the treatment was ended with only the remaining volumes in both the return and treatment bags manually returned to the patient.The customer stated that the patient was in stable condition.The kit, smart card, and photos will be submitted for investigation.

Manufacturer Narrative

The customer decided not to return either the kit or the smart card for investigation.A photo analysis was conducted for this complaint.A review of the photos confirmed the occurrence of the alarm #8: blood leak (photoactivation chamber) alarm, as the alarm could be seen on the instrument's monitor within the photos.An evaluation of the photos also confirmed the leak, as the photos showed what appeared to be bubbles/foam coming from the plate.These bubbles/ foam are an indication of a possible breach within the plate, however the exact nature of the breach could not be determined due to the bubbles/foam obscuring its view.The root cause for the leak could not be determined based on the available information.The device history record review did not result in any related non-conformances and this kit lot had passed all lot release testing.A material trace of the illumination plate used to build this kit lot also did not find any related non-conformances.Each plate is visually inspected during production in order to detect any defects, particulates, cracks, chips, scratches or voids.Each plate is also leak tested prior to being released.Re-training has recently been performed with the relevant operators who perform this plate inspection task in order to ensure that the inspection of the plates is being carried out thoroughly.No further action required.This investigation is now complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; 53 frontage road; bedminster, NJ 07921
• MDR Report Key: 6652718
• MDR Text Key: 78094692
• Report Number: 2523595-2017-00112
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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: 61 YR
• Patient Weight: 50