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 01/27/2017

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.No information was available to assess if the ecp treatment could have caused or contributed to the patient's death.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 23-feb-2016.As part of the review, it was determined that after 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 (b)(6) 2017.The customer reported that the patient's dvt was treated with tinzaparin.The customer stated that the patient had multiple risk factors for venous thromboembolisms.The customer reported that the patient had undergone 17 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 is currently deceased.The patient's cause of death, date of death, and its relationship to this adverse event were requested but not provided as of the date of this report.No product was specified in the complaint.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 last ecp treatment was on (b)(6)2017.The customer stated that the patient passed on (b)(6)2017 due to infection, multi-organ failure, and graft versus host disease (gvhd).The customer reported that the patient's infection, multi-organ failure and death were due to the immunosuppression required to treat the patient's gvhd.The customer stated that the patient's death was unrelated to their reported deep vein thrombosis and also unrelated to their ecp treatments.There was no specific cellex instrument serial number mentioned in the complaint, however there are only two cellex instruments at this site, (b)(4) and (b)(4).Instrument 40616 did not undergo any service prior to the patient's adverse event.No service was requested by the customer for this adverse event.Following the event, instrument 40616 underwent preventive maintenance 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.Instrument 40617's last service prior to the patient's adverse event was performed on (b)(6)2016.No service was requested by the customer for this adverse event.Following the event, instrument 40617 underwent preventive maintenance 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.Mc 028301 s.K.6/11/208.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 7509381
• MDR Text Key: 108089236
• Report Number: 2523595-2018-00082
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• 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