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 Embolism (1498); Dyspnea (1816); Respiratory Failure (2484)

Event Date 04/18/2018

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 bilevel positive airway pressure heparin, and lovenox that were provided to the patient.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.An instrument serial number was not provided within the user facility report thus a device service history review could not be conducted for this case.Trends were reviewed for complaint categories, shortness of breath, respiratory failure, and pulmonary embolism.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: dyspnea, respiratory failure, and pulmonary embolism.(b)(4).

Event Description

The below user facility report, mw5077642, was discovered in the fda's maude database during an annual review.As we were unable to reconcile this report, it was added to our complaint database and determined to be reportable.As the reporter was not identified within user facility report, a follow-up could not be performed regarding this report.The patient had been receiving one to two extracorporeal photopheresis (ecp) treatment procedures for the treatment of chronic graft versus host disease (cgvhd) since 2016.The patient's cgvhd symptoms resulted primarily in significant sclerodermatous changes that affected the patient's extremities and trunk.These sclerodermatous changes caused the patient to experience dyspnea.The patient was seen for her routine outpatient ecp treatment procedure on an unknown date in 2018.Prior to her ecp treatment procedure, the patient reported that she had been diagnosed a week earlier with an upper respiratory infection.The patient stated that she was currently being treated with a course of azithromycin and advair for her upper respiratory infection.Heparin had been used as the anticoagulant for the patient's ecp treatment procedure and the patient's ecp treatment procedure was uneventful.On (b)(6) 2018 the patient went to the emergency room due to worsening dyspnea.The patient was ultimately admitted to the medical intensive care unit for respiratory failure.The patient's lab results were significant for the findings of a new pulmonary embolism at the bifurcation of her left main pulmonary artery.This pulmonary embolism, along with her upper respiratory infection and underlying gvhd condition, was thought to have contributed to the patient's respiratory distress.The patient was stable on bilevel positive airway pressure and was also receiving both antibiotics and heparin.In addition, the patient was transitioning from heparin to lovenox.

• 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: 9211388
• MDR Text Key: 175756511
• Report Number: 2523595-2019-00125
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2019

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/18/2019
• 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): Required Intervention