MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem Thrombosis (2100)

Event Date 06/29/2017

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 tinzaparin that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no instrument issue was alleged by the customer.No service was requested by the customer for this adverse event.There was no specific cellex instrument serial number mentioned in the complaint; however, there are only two cellex instruments located at this customer's site, instrument serial numbers (b)(4).No product was returned; therefore, a device service history review was performed.Cellex instruments, (b)(4) , have been located at the customer's site since (b)(6) 2016.As part of the review, it was determined that prior to the event the instruments, (b)(4), underwent scheduled preventive maintenance on 01-mar-2017.The instruments' last service was performed on 27-feb-2018 and 28-feb-2018, respectively.During all of these services the system checkout procedure was successfully completed indicating that the instruments had passed all tests, met all specifications, and were operational.Trends were reviewed for complaint category, thrombosis.No trends were detected for this complaint category.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: thrombosis.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced a deep vein thrombosis (dvt).The customer stated that the patient's dvt was diagnosed through a doppler ultrasound study on 29 june 2017.The customer reported that the patient's dvt was treated with tinzaparin.The customer stated that the patient's significant immobility was a risk factor for dvts.The customer reported that the patient had undergone five cycles of ecp treatments prior to their dvt diagnosis.The customer stated that the patient's last ecp treatment prior to their dvt diagnosis was on (b)(6) 2017 and acda was used as the anticoagulant in that treatment at a 12:1 ratio.The customer reported that the patient was still continuing with their ecp treatments.No product was returned for investigation.

Manufacturer Narrative

In a follow up with the customer on (b)(6) 2018, the customer stated that the patient continued with their extracorporeal photopheresis (ecp) treatments after their deep vein thrombosis diagnosis on (b)(6) 2017.The customer reported that the patient's ecp treatments are still ongoing.There was no specific cellex instrument serial number mentioned in the complaint, however there are only two cellex instruments at this site, 40616 and 40617.Instrument 40616 underwent preventive maintenance on (b)(6) 2017 prior to the adverse event.No service was requested by the customer for this adverse event.Following the event, instrument 40616 underwent unrelated service on (b)(6) 2017.During each of the services the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational each time.Instrument 40617 underwent service on (b)(6) 2017 prior to the patient's adverse event.No service was requested by the customer for this adverse event.Following the event, instrument 40617 underwent unrelated service on (b)(6) 2017.During each of the services the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational each time.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 7509595
• MDR Text Key: 108094388
• Report Number: 2523595-2018-00085
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention