MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

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

Patient Problems Swelling (2091); Thrombosis (2100)

Event Date 05/21/2018

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 xarelto that was 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 performed as an instrument serial number was not provided.Trends were reviewed for complaint categories swelling and thrombosis.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: swelling and thrombosis.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced swelling and a deep vein thrombosis following a treatment procedure.The customer stated that the patient had received their ecp treatments from (b)(6) 2017 through (b)(6) 2019 for chronic graft versus host disease.The customer reported that the patient presented to the bone and marrow transplant clinic on (b)(6) 2018 with complaints of left lower extremity swelling.The customer stated that a doppler ultrasound was performed with indicated a deep vein thrombosis.The customer reported that on (b)(6) 2018, the patient was started on anticoagulation therapy with xarelto.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 customer on (b)(6) 2020.Please see sections b5, b6, b7, d4, h4 and h6 of this report for the additional information.A device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2015.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 2017.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Comp-001705 s.K.(b)(6) 2020.

Event Description

The customer reported on (b)(6) 2020 that heparin at a 10:1 ratio was used as the anticoagulant for the patient's extracorporeal photopheresis (ecp) treatments.The customer stated that the patient continued with their ecp treatments after their deep vein thrombosis (dvt) diagnosis on (b)(6) 2018 with the patient's last ecp treatment on (b)(6)2019.The customer reported that the patient was in stable condition.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 9821753
• MDR Text Key: 189868337
• Report Number: 2523595-2020-00050
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR