MAUDE Adverse Event Report: THERAKOS, INC XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Type  Death  

Manufacturer Narrative

The system was used for treatment.From a device perspective, there was no known device malfunction and no instrument issue was alleged by the presenter.However, 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 instrument's serial number was not provided in the presentation; therefore, the device history review could not be conducted.Trends were reviewed for complaint categories: death and pulmonary embolism.No trends were detected for these complaint categories.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 pulmonary embolism.(b)(4).

Event Description

The information for this case came from a german presentation on the use of ecp in patients diagnosed with chronic lung allograft dysfunction (clad) following lung transplantation.The presentation mentioned that 25 out of 252 patients stopped ecp treatment.Two of the 25 patients stopped ecp treatment due to "related" deaths from air embolisms.It is unclear if the "related" deaths were due to the patients' underlying condition or due to their ecp treatment.In a follow-up communication with the presenter could only confirm that one of the deceased patients had been receiving treatment with a therakos device.No product was returned for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; bedminister NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 6749175
• MDR Text Key: 81226595
• Report Number: 2523595-2017-00159
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• 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: XTS
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• 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