MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS XTS SYSTEM

Lot Number C713 - KIT

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

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Blurred Vision (2137)

Event Date 07/03/2014

Event Type  Injury  

Event Description

Cbs on site for training purposes became aware of the following event, during conversation with patient and family.In a previous treatment on (b)(6) 2014, (day two of first ecp cycle), patient started to feel unwell at the end of the 5th cycle.Numbness of the entire fact, unclear vision on both sides adn change of taste in the mouth, with slight pressure in the head, and dull ears.Patient said she did not eat prior to treatment.Blood pressure was 160/100 at the time, other vital parameters were normal.Improvement of all symptoms after a few minutes, and treatment could be completed normally.Neurological examination: conscious, no neck stiffness, orientated, cooperative, normal speech, olfactory sensation subjectively normal.Pupils moderately dilated, isochoric.Reaction to light on both sides promptly, directly and indirectly triggered.Visual field testing unremarkable.Ocular motility normal.No pathological nystagmus, no double images.No hypoacusis, non tinnitus.Tonus, strength, reflexes on all sides normal.No hemiplegic symptoms, no neurological deficits.Anamnesis: double lung transplant for cystic fibrosis on (b)(6) 2003.Ecp started after deterioration of lung function and symptoms of rejection since two months.Bos diagnosed after bronchoscopy on (b)(6) 2014.Update: (b)(6) 2014: a complete treatment was done with six cycles.After improvement of the symptoms, the fifth cycle was continued, as well as the sixth.After collecting the final bc, uvadex was administered with subsequent photo activation.Apart from the neurological investigation, no other examination was done.No prolonged hospital stay.Patient received another ecp treatment the next day and left the hospital as planned in the afternoon.Patient received her next (second) treatment cycle as planned after two weeks, no problems then.Patient confirmed that from the second procedure on all went fine and that she could normally tolerate the ecp.

Manufacturer Narrative

A review of lot c713 was conducted.There were no non-conformances associated with this lot.The lot met release requirements.Trends have been reviewed for this complaint category and no trends have been detected for altered taste, blurred vision, hypertension and headache.The assessment is based on information available at the time of the investigation.No product was returned for investigation.There is no evidence instrument did not functioned as intended.This report is being created to document the patient's unexpected reaction during treatment.Conclusion: currently, no evidence of focal neurological deficits.Complaints most likely circulatory associated.(b)(4).

• Brand Name: THERAKOS XTS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, 140; bridgewater, NJ 08807
• MDR Report Key: 4058908
• MDR Text Key: 4812659
• Report Number: 2523595-2014-00223
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/22/2014

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: Health Professional
• Device Expiration Date: 03/01/2019
• Device Lot Number: C713 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 54