MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Type  Death  

Manufacturer Narrative

The system was used for treatment.The instrument's serial number was not provided in the article; therefore, a device history review could not be conducted.Trends were reviewed for complaint categories, death and infection.No trends were detected for these complaint categories.From a device perspective, there was no known device malfunction and no instrument issue was alleged in the article.The author of the article was contacted in order to obtain additional information concerning the article, however a response has not been received.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 and infection.(b)(4).

Event Description

In an article written by denney et al.(transplantation (2016) volume 00, number 00, issn: 0041-1337/16/0000-00) titled "regulatory t cells in chronic graft-versus-host disease after extracorporeal photopheresis: correlation with skin and global organ responses, and ability to taper steroids", a study was performed in great britain on patients being treated for graft versus host disease (gvhd) using extracorporeal photopheresis (ecp).The authors of the article were trying to demonstrate that ecp treatments could reduce the need for steroidal medication in ghvd patients.The article stated that "corticosteroids and immunosuppressive drugs are common treatments for chronic gvhd, but the resulting unpredictable and variable response rates, toxicities, and profound immunodeficiency can cause death from infection." the study consisted of 32 adult patients who were diagnosed with chronic gvhd.At the start of the study, 78% of the patients had skin [gvhd] involvement and 91% were on steroids.The article reported that four patients did not complete the twelve month study due to death from infections.The article stated that these patients had passed within 8 months of commencing ecp treatments, however the exact length of their respective ecp treatments is unknown.No specific date of death was provided for these patients as there was no further information regarding these patients within the article.

• 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: 6631224
• MDR Text Key: 77250725
• Report Number: 2523595-2017-00113
• 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: 06/09/2017

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: 05/30/2017
• Initial Date FDA Received: 06/09/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death