MAUDE Adverse Event Report: THERAKOS INC. / MALLINCKRODT PHARMACEUTICALS IRELAND LTD. CELLEX SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Pulmonary Embolism (1498)

Event Date 11/21/2018

Event Type  Injury  

Event Description

A pulmonary emboli (pe) was diagnosed in a pt receiving extracorporeal photopheresis (ecp) treatment via the celex system for bronchiolitis obliterans syndrome (bos).Symptoms started (b)(6) 2018 (two days prior to admission) and consisted of dyspnea on exertion along with decreased exercise tolerance and cough.The pt presented to a local emergency dept and was found to be hypoxemic (room air sao2 were 86%) and tachycardic (150s).Ct demonstrated bilateral subsegmental pe and the pt was transferred to (b)(6) hosp.The pt was admitted (b)(6) 2018.The pt was started on a heparin infusion and transitioned to apixaban for anticoagulation.The pt was on 4 liters of oxygen on admission and weaned down to room air and hemodynamically stable.Pt was discharged (b)(6) 2018.It is noted that the pt travels once a week from (b)(6) to (b)(6) by car for the ecp treatments.This is a 7 hr car ride.The pt reportedly takes one to two breaks during the car ride.No history of dvt or pe.The pt is participating in a (b)(6) in (b)(6) eligible recipients of lung allografts ((b)(6)).The pt is scheduled for 24 ecp treatments in 6 month period.The last ecp treatment prior to this pe event was 4 days prior to the event ((b)(6) 2018) which was the participants 10th ecp treatment.The pt's pe symptoms started four days after the last ecp treatment (b)(6) 2018.The pe was reported to be possibly related to the ecp treatment although the pt's recent travel was also a suggested risk factor for pe.In light of the (b)(6) 2018 safety report describing reports of venous thromboembolism in pts receiving autologous immune cell therapy with the cellex photopheresis system we felt that it was appropriate for us to submit a report through medwatch.It is noted that the onset of these events in the safety alert occurred during, or shortly after (mean of 1.2 days) active treatment sessions.

• Brand Name: CELLEX SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS INC. / MALLINCKRODT PHARMACEUTICALS IRELAND LTD. ; bedminster NJ
• MDR Report Key: 8151279
• MDR Text Key: 130207487
• Report Number: MW5082020
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 97