MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

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

Patient Problems Edema (1820); Thrombosis (2100); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the blood thinners that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.A device service history review could not be peformed as an instrument serial was not provided.Trends were reviewed for complaint categories, edema, thrombosis, and onycholysis.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: edema, thrombosis, no code available: onycholysis (b)(4).

Event Description

The patient reported that on (b)(6) 2020 that she had an appointment.The patient stated that she was in remission.The patient reported that they took out her peripherally inserted central catheter and she was so happy.The patient stated that she did not have to do anymore chemo.The patient reported that for 15 years she did not have to do chemo and was stable due to her extracorporeal photopheresis (ecp) treatments.The patient stated that she will be monitored over the next few years.The patient reported that she also had a swollen leg while in the hospital due to a blood clot.The patient stated that the blood clot was located below her knee.The patient reported that she was given blood thinners for the blood clot.The patient stated that she takes four blood thinners a day; two in the morning and two at night.The patient stated that she was losing her fingernails, which she was not happy about.No product was returned for investigation.

Manufacturer Narrative

This supplemental / follow-up report was written in order to capture the additional information that was provided by the patient on 24-mar-2020.Please see section b-5 of this report for the additional information.(b)(6).S.K.(b)(6) 2020.

Event Description

The patient reported on (b)(6) 2020 that she was doing fine.The patient stated that she had just emailed the university of (b)(6) in order to fill a prescription.The patient reported that she is currently not undergoing extracorporeal photopheresis (ecp).The patient stated that she had stopped her ecp treatment procedures while she was undergoing intensive chemotherapy for the past few months.The patient reported that she was waiting to hear if she could resume her ecp treatment procedures after her magnetic resonance imaging (mri) test on (b)(6) 2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 9684762
• MDR Text Key: 191913739
• Report Number: 2523595-2020-00033
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR