MAUDE Adverse Event Report: THERAKOS, INC XTS PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Toxicity (2333)

Event Type  Injury  

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 categories, equipment performance, infection, hypotension, hypertension, and other adverse event: citrate toxicity.No trends were detected for these complaint categories.From a device perspective: as it is unknown why these patients required blood products, the device cannot be ruled out as a contributing factor in this event.This case will be reported as an 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: infection, hypotension, hypertension, and toxicity (citrate).(b)(4).Device not returned to manufacturer.

Event Description

In an article written by kapadi et al., pediatr blood cancer 2015;62:1485-1488, an institutional review board study was performed on patients being treated for graft versus host disease (gvhd) using extracorporeal photopheresis (ecp).The study took place from september 2010 to may 2014.The article stated that eight ecp treatments were terminated early secondary to patient hemodynamic instability, line occlusions, or alarms (the actual alarms were not specified in the article).The article reported that technical complications, including line occlusions requiring tissue plasminogen activator (tpa) and instrumental alarms, occurred 31 times during the study.The article reported that there were 18 hypotensive episodes requiring fluid boluses in patients undergoing ecp treatment during this study.The article stated that all of the hypotensive episodes occurred in patients that weighed less than (b)(6).The article reported that there were four hypertensive episodes in patients undergoing ecp treatment during this study.The article stated that there were two instances of catheter associated infections during the study.The article also reported that there were 32 incidents where blood products were required and five incidents of citrate toxicity during the study.The article did not specify if these events occurred before or after drug administration or even what drug was used during the study.No other information regarding these patients was provided in the article.The instrument was not returned for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS 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: 6503190
• MDR Text Key: 73117389
• Report Number: 2523595-2017-00080
• 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: 04/19/2017

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: XTS
• 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: 04/19/2017
• 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): Life Threatening; Required Intervention