MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The system was used for treatment.The instrument's serial number was not provided in the article; therefore, the device history review could not be conducted.Trends were reviewed for complaint category, death.No trends were detected for this complaint category.From a device perspective: since the device could not be ruled out as a possible contributing factor to this event, this case will be reported as a mdr out of an abundance of caution.Since this event is associated with the treatment, this mdr will be against the instrument.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: death.(b)(4).Device not returned to manufacturer.

Event Description

During a literature review of an article written by kapadi et al., pediatr blood cancer 2015;62:1485-1488, it was noted that a patient death was reported.The article stated that an institutional review board study was performed.This study took place from september 2010 to may 2014.The article mentioned that patient #10 (referenced as such in the article), passed away from multi-organ failure.No specific date of death was provided for this patient in the article.The patient was being treated for acute graft versus host disease (ghvd).This patient had a site/stage overall gvhd grade of ii (gut-1).According to the article, this patient was treated for one month and their response to the extracorporeal photopheresis (ecp) treatments was considered to be stable and active.Prior to ecp, the patient was treated with prednisone.During the ecp treatments, this patient was treated with prednisone and rapamycin.No other information regarding this patient was provided in the article.The instrument was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6502635
• MDR Text Key: 73093948
• Report Number: 2523595-2017-00079
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death