MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Pulmonary Infarction (2021); Thrombosis (2100)

Event Date 03/19/2018

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 rivaroxaban that was given to the patient and to the permanent damage of a body function/structure (pulmonary infarct).This case is also reportable as a mdr due to the patient's hospitalization.Based on the available information, it could not be determined if the patient's ecp treatment could have contributed to the reported pulmonary infarct or if the pulmonary infarct was due to the patient's underlying conditions.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.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2015.The customer has their own bio-medical engineer who performs all the service and maintenance for this instrument.Trends were reviewed for complaint categories, thrombosis and other adverse event: pulmonary infarct.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: thrombosis and pulmonary infarction.(b)(4).

Event Description

The customer called to report that an extracorporeal photopheresis (ecp) patient experienced a deep vein thrombosis (dvt).The customer stated that the patient's dvt was diagnosed on (b)(6) 2018 using bilateral lower-extremity venous doppler ultrasound.The customer reported that the patient was admitted to the hospital on (b)(6) 2018.The customer stated that a ct scan also showed that the patient experienced a pulmonary infarction and a pulmonary embolism was suspected.The customer reported that they believed that the patient's dvt diagnosis could be related to both the patient's underling condition and their ecp treatment.The customer stated that the patient had undergone eight ecp treatments prior to their dvt diagnosis.The customer reported that the patient's last ecp treatment prior to their dvt diagnosis was on (b)(6) 2018 and heparin was used as the anticoagulant in that treatment at an 8:1 ratio.The customer stated that as of (b)(6) 2018, the patient was still in the hospital.The customer reported that the patient has not continued with their ecp treatments.In a follow up with the customer on (b)(6) 2018, the customer stated that the patient experienced a dvt in both legs.The customer reported that the patient's discharge note stated that a ct scan showed a left lower lobe pulmonary infarction concerning for a pulmonary emboli.The customer stated that the patient was started on rivaroxaban while in the hospital with plans to continue with this therapy for three months.The customer reported that the patient had been discharged from the hospital (the customer did not provided the exact date of discharge) with the following medications: valganciclovir, vancomycin, lisinopril, sirolimus, calcium carbonate, magnesium oxide, k-dur, lasix, diuril, aldactone, tramadol, and tylenol (prn).The customer stated that an angiodynamic dual lumen port had been used for the patient's ecp treatments and there were no plans to restart the patient's treatments.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: 7448233
• MDR Text Key: 106144141
• Report Number: 2523595-2018-00063
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/20/2018

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: Nurse
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2015
• 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; Disability
• Patient Age: 20 YR
• Patient Weight: 79