MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number C356

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

Patient Problem Swelling (2091)

Event Date 01/20/2014

Event Type  Injury  

Event Description

Customer called to report patient complained of swelling of lips, right eye, and legs, and some wheezing.Customer stated patient's last ecp treatment was on (b)(6) 2015.Patient returned on (b)(6) 2015 presenting swelling of lips, legs, and right eye was swollen shut.After assessing the patient, physician canceled patient's treatment procedure.Physician also prescribed 50 mg of benadryl.The patient has had 4 ecp treatments in total, including yesterday's treatment.Customer stated the treatment was completed successfully, 1552 ml whole blood was processed.Css asked how much uvadex was administered to the patient after treatment procedure yesterday, customer stated 3.1 ml.The customer stated she had discarded the uvadex bottle and did not have the lot number available.Customer stated there was nothing remarkable about the uvadex vial or the contents of the vial.The vial still completely sealed.Customer stated the patient did not have any complaints before during or after the procedure.There were no alarms during prime and/ or procedure.Customer stated the patient will not be receiving any more ecp treatments until further assessment.There was no product returned for investigation.

Manufacturer Narrative

A review of lot c356 was performed and there were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not reported so no batch record review was performed.A review of complaint categories shows no trends for this type of event.No capa has been initiated.Based on the medical assessment, (b)(6) female with sezary syndrome developed swelling of lips, legs, and right eye that was swollen shut the day after the fourth treatment.After assessing the patient, physician canceled patient's treatment procedure.Physician also prescribed 50 mg of benadryl.Patient had no complaints before, during or after treatment.It is unknown to what caused the patient's angioedema but uvadex/ecp cannot be ruled out.Medical intervention was necessary.Patient was stable after the administration of benadryl.No other treatments are scheduled for this patient.This case is considered serious.This assessment is based on information available at the time of investigation.No product was returned for investigation; therefore it could not be determined if the product met specifications based solely on information provided by the customer.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east, suite 140; bridgewater, NJ 08807
• MDR Report Key: 4493680
• MDR Text Key: 16172240
• Report Number: 2523595-2015-00029
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/20/2015

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: 11/01/2016
• Device Lot Number: C356
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 49