CELLEX SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for CELLEX SYSTEM manufactured by Therakos, Inc. / Mallinckrodt Hospital Products, Inc..

Event Text Entries

[183352079] Pulmonary emboli (pe) was diagnosed in a pt who had received 18 extracorporeal photopheresis (ecp) treatments via the cellex system. Bronchiolitis obliterans syndrome (bos). The pt received is 18th ecp treatment on (b)(6) 2019. The pe event occurred on (b)(6) 2019. The pi reported no relationship. The pt was hospitalized for the event. The pt was initially evaluated in clinic for increased shortness of breath and admitted to the hosp. Ct chest without contrast (b)(6) 2019: postoperative change from bilateral lung transplant, eccentric nonocclusive filling defect within the right main pulmonary artery proximal to the pulmonary artery anastomosis measuring 2. 9 x 1. 6 cm. Findings are consistent with thrombus; however, the chronicity is uncertain and could be acute or chronic; new bilateral groundglass and patchy consolidative opacities most severely affecting the left upper lobe. Findings favor multifocal infection; diffuse mosaic attenuation of the lungs most commonly associated with air trapping / constrictive bronchiolitis; new 4mm right upper lobe nodule may be inflammatory, however recommend 3 month f/u to ensure stability; aortic and coronary artery atherosclerosis. Stable mild dilation of the mid ascending aorta measuring 4 cm. The main pulmonary artery is dilated; pneumobilia which is new from the prior correlate with interval interventions. Treated with heparin drip and changed to oral anticoagulation. The pt received 18 ecp treatments for bronchiolitis obiterons syndrome: (b)(6) 2019, (b)(6) 2019, (b)(6) 2019, (b)(6) 2019. Following the pe event the pt resumed ecp treatments and completed 24 total.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093661
• MDR Report Key: 9818142
• Date Received: 2020-03-10
• Date of Report: 2020-03-06
• Date of Event: 2019-06-21
• Date Added to Maude: 2020-03-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CELLEX SYSTEM
• Generic Name: SYSTEM, PHOTOPHERESIS, EXTRACOPOREAL
• Product Code: LNR
• Date Received: 2020-03-10
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THERAKOS, INC. / MALLINCKRODT HOSPITAL PRODUCTS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2020-03-10