MAUDE Adverse Event Report: HARMAC MEDICAL PRODUCTS THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number	D732 - KIT
Health Effect - Clinical Codes	Fainting (1847); Low Blood Pressure/ Hypotension (1914)
Date of Event	01/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This system was used for treatment.A review of kit lot d732 was performed.There were no nonconformances related to this complaint.This lot met release requirements.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint category fainting.No trend was identified for this issue.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).Device not returned.
Event or Problem Description
The patient fainted (for a duration of approximately 1 minute) while the clinical services specialist (css) was on site for training.This event occured during buffy coat in the 3rd of 4 cycles.The patients blood pressure dropped to 80/50.The treating physician administered 100 ml of saline and about 300 ml of electrolyte solution.The patient was brought into a vertical position and his blood pressure stabilized.Afterwards, the patient stated that he had not been feeling well all week but he had not mentioned this when asked about his well being prior to the start the extracorporeal photopheresis (ecp) treatment.Ecp was completed.The patient was monitored for several hours.No further episodes occurred.During css follow up it was confirmed that the patient remained stable and received an ecp treatment the next day without issue.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• MDR Report Key: 5459043
• Report Number: 2523595-2016-00021
• Device Sequence Number: 16242268
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/25/2016

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
• Operator of Device: Nurse
• Device Expiration Date: 09/01/2020
• Device Lot Number: D732 - KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2016
• Initial Report FDA Received Date: 02/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 64