MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

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

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Hypoxia (1918); Tachycardia (2095); Thrombosis/Thrombus (4440); Wheezing (4463)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and also due to the medical intervention of the oxygen, heparin, and eliquis that were 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 peformed as an instrument serial number was not provided.Trends were reviewed for complaint categories, pulmonary embolism, dyspnea, tachycardia, wheezing, hypoxemia, 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: pulmonary embolism, dyspnea, thormbosis/thrombus, tachycardia, wheezing, and hypoxia.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced shortness of breath, wheezing, heart rate increase, hypoxemia, a thrombosis, and a pulmonary embolism following a treatment procedure.This patient is a participant in the (b)(6).The clinical research specialist reported that the patient enrolled in the clinical trial on (b)(6) 2019.The clinical research specialist stated that on (b)(6) 2020 the patient awoke at 0300 with dyspnea.The clinical research specialist reported that the patient had been using inhaled ceftazidime for the past couple of days.The clinical research specialist stated that the patient felt tightness in her chest and was wheezing.The clinical research specialist reported that the patient was barely able to walk to the bathroom.The clinical research specialist reported that the patient did not experience any chest pain or lower extremity pain.The clinical research specialist stated that the patient's cough was not much different than it was over the past couple of weeks.The clinical research specialist reported that the patient experienced severe dyspnea with minimal activities.The clinical research specialist stated that the patient's dyspnea was made worse with recumbency.The clinical research specialist reported that the patient's dyspnea was not associated with chest pain.The clinical research specialist stated that the patient went to their local emergency department on (b)(6) 2020.While in the emergency department, the clinical research specialist reported that the patient was found to be both tachycardic and hypoxemic which were both resolved with the administration of two liters of oxygen by nasal cannula.The clinical specialist stated that the patient was admitted to the hospital on (b)(6) 2020.The clinical research specialist reported that a ventilation-perfusion (vq) scan was performed on (b)(6) 2020, which showed several wedge like abnormalities felt to be a pulmonary embolism.The clinical research specialist stated that on (b)(6) 2020, an ultrasound was performed on both the patient's lower and upper extremities and there was no evidence of a deep venous thrombosis in either of the patient's lower or upper extremities.The clinical research specialist reported that a nonocclusive superficial thrombosis was found in the patient's right cephalic vein at the antecubital fossa.The clinical research specialist stated that the patient was placed on a heparin drip along with a higher dose of steroids for their wheezing on (b)(6) 2020.The clinical research specialist reported that the patient underwent a ct angiography of their thorax on (b)(6) 2020, which confirmed an acute right lower lobe segmental/subsegmental pulmonary embolism.The clinical research specialist stated that the ct scan showed no evidence of right heart strain.The clinical research specialist reported that the ct scan indicated stable mosaic attenuation of the lung parenchyma with stable branching modular opacity in the right lower lobe.The clinical research specialist stated that on (b)(6) 2020, the patient was switched from their heparin drip to oral eliquis and was discharged home.The clinical research specialist reported that the patient's last ecp treatment procedure prior to their pulmonary embolism diagnosis was on (b)(6) 2020 and heparin was used as the anticoagulant for this ecp treatment procedure.The clinical research specialist stated this ecp treatment procedure was successfully completed without any issues or complications.The clinical research specialist reported that the patient continued with their ecp treatment procedures following their pulmonary embolism diagnosis.The clinical research specialist stated that the patient underwent another successfully completed ecp treatment procedure on (b)(6) 2020.The clinical research specialist reported that the patient's pulmonary embolism was related or possibly related to the patient's ecp treatment, to methoxsalen, to the patient's central venous catheter, and to their research study.The clinical research specialist stated that the patient's pulmonary embolism was not considered fatal or life threatening, and was also not unexpected for this patient.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 11144448
• MDR Text Key: 231962883
• Report Number: 2523595-2021-00010
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 104