MAUDE Adverse Event Report: THERAKOS, INC/MALLINCKRODT PHARMACEUTICAL CELLEX SYSTEM; SYSTEMS, PHOTOPHERESIS, EXTRACORPOREAL

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

Patient Problems Dyspnea (1816); Embolism (1829); Thrombosis (2100)

Event Date 11/14/2019

Event Type  Injury  

Event Description

Pulmonary emboli (pe) and a deep vein thrombosis (dvt) was diagnosed in a patient receiving extracorporeal photopheresis (ecp).Treatment via the callex system for bronchiolitis obliterans syndrome (bos).The patient went to an outlying emergency department with complaints of shortness of breath and cough that started one hour prior to arrival.No chest pain.+tachypneas.Ct scan with contrast suggestion of a right middle lobe pulmonary embolism.Groundglass infiltrates lung bases right side greater than left.Patient was initially treated with lovenox and methylprednisolone and transferred to bjc.Lovenox was changed to heparin drip.(b)(6) 2019 lower extremity ultrasound showed acute deep vein thrombosis in the right posterior tibial and peroneal veins.No evidence of dvt in the left leg.Ct with contrast repeated (b)(6) 2019 showed pulmonary embolism involving the loar, segmental, and subsegmental branches of the right main pulmonary artery.No evidence of right heart strain.Groundglass opecities within the lung bases, right greater than the left, favored to represent an infectious inflammatory etiology versus scarring in the setting of bilateral lung transplantation.The patient had received 15 ecp treatments prior to the pe / dvt event.The pe/dvt event took place eight days after the last ecp treatment.The event was not related to the catheter used for the purpose of performing ecp.The physician felt the event was possibly related to the research.This event is being reported in light of the fda safety alert sent february 2018.

• Brand Name: CELLEX SYSTEM
• Type of Device: SYSTEMS, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC/MALLINCKRODT PHARMACEUTICAL; bedminster NJ
• MDR Report Key: 9774680
• MDR Text Key: 181810355
• Report Number: MW5093400
• 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: 02/25/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 92