MAUDE Adverse Event Report: THERAKOS, INC. / MALLINCKRODT HOSPITAL PRODUCTS, INC. CELLEX SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACOPOREAL

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

Patient Problem Pulmonary Embolism (1498)

Event Date 06/21/2019

Event Type  Injury  

Event Description

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.

• Brand Name: CELLEX SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACOPOREAL
• Manufacturer (Section D): THERAKOS, INC. / MALLINCKRODT HOSPITAL PRODUCTS, INC.
• MDR Report Key: 9818142
• MDR Text Key: 183352079
• Report Number: MW5093661
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 66 YR
• Patient Weight: 86