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); No Code Available (3191)

Event Date 10/29/2019

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 heparin, augmentin, lovenox, coumadin, and prednisone 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 performed as an instrument serial number was not provided.Trends were reviewed for complaint categories shortness of breath, hypoxia, tachycardia, cough, 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, hypoxia, tachycardia, no code available: cough, and pulmonary embolism.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced shortness of breath, hypoxia, severe cough, tachycardia, and a pulmonary embolism during a treatment procedure.This patient is a participant in (b)(6).The customer stated that the patient developed sudden shortness of breath, severe cough, and hypoxia (oxygen desaturation down to 82%) ten minutes into his ecp treatment procedure.The customer reported that the patient also became acutely tachycardic with a heart rate in the 140s.The customer stated that the patient improved somewhat with supplemental oxygen (25 liters via nasal cannula), but the patient's significant shortness of breath persisted.The customer stated that the rapid response team was called and the patient was transported to the emergency department.The customer reported that upon arrival to the emergency department, the patient was tachycardic with a heart rate in the 150s.The customer stated that the patient was experiencing increased work of breathing so the patient was placed on a bilevel positive airway pressure machine.The customer reported that the patient's lab work also revealed elevated lactate.The customer reported that a computed tomography angiography (cta) was performed which was positive for a segmental right lower lobe pulmonary embolism and bilateral patcy ground glass opacities.The customer stated that the patient was started on a heparin drip and transferred to the intensive care unit (icu) for further evaluation and management.The customer reported that while in the icu the patient was started on anticoagulants, broad sputum antibiotics, and high dose steroids.The customer stated that gradually the patient's o2 requirements improved.The customer reported that a bronchoscopy showed only minimal secretions and the patient's cultures revealed gram-negative rod infections.The customer stated that the patient's cardiac workup was unremarkable.The customer stated that the patient's overall clinical picture was suggestive of multifactorial lung injury secondary to low lung reserve due to an underlying chronic lung allograft dysfunction, the pulmonary embolism, and an evolving infection.The customer reported that the patient's o2 requirements had further improved and were down to room air.The customer stated that the patient was discharged from the hospital on (b)(6) 2019 with the following medications; augmentin, lovenox, coumadin and a prednisone taper.The customer reported that upon discharge the patient's pulmonary effort was normal and there was no respiratory distress.The customer stated that the patient had normal breath sounds with no stridor.The customer reported that the patient's discharge diagnosis was pulmonary embolism and pneumonia.The customer stated that the patient has continued with their ecp treatments.The customer reported that the patient underwent an ecp treatment procedure on (b)(6) 2019 and this treatment was successfully completed without any issues.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: 9804019
• MDR Text Key: 196409128
• Report Number: 2523595-2020-00047
• 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: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/07/2020
• Initial Date FDA Received: 03/08/2020
• 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
• Patient Age: 48 YR
• Patient Weight: 55