MAUDE Adverse Event Report: THERAKOS, INC. / MALLINCRODT PHARMACEUTICALS, IRELAND LTD. CELLEX SYSTEM; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

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

Patient Problems Pain (1994); Skin Discoloration (2074); Swelling (2091); Tingling (2171); Numbness (2415)

Event Date 10/20/2019

Event Type  Injury  

Event Description

Pulmonary emboli (pe) and deep vein thrombosis (dvt) was diagnosed in a pt receiving extracorporeal photopheresis (ecp) treatment via the cellex system for bronchiolitis obliterans syndrome (bos).The patient presented to a local emergency department on (b)(6) 2019 with one day history of left leg swelling and pain, on arrival at the ed the patient also had numbness tingling to the left leg.Denied chest pain.Denied shortness of breath.O2 sat is 99% on room air.Bp 101/64, heart rate 96, respirations 20.Good dorsalis pedis pulse in left foot.No posterior tibia palpated or dopplered.Left leg cyanotic.Patient transferred to the university medical center.Vital signs remained stable.On room air.No sob, no chest pain, no abdominal pain, no back pain.Continued to have left leg pain swelling and discoloration.Ct angiography obtained.Results below.Heparin drip started and morphine given.Later transitioned to apixaban.No history of blood clots.Patient was not on any blood thinners at the time of the dvt/pe diagnosis.Left leg swelling and symptoms started 4 - 5 days following the patient's 5th ecp treatment.- of note the patient later reported a recent trip from (b)(6) for a karate tournament (b)(6) 2019.This is a 15 hour drive.

• Brand Name: CELLEX SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC. / MALLINCRODT PHARMACEUTICALS, IRELAND LTD. ; bedminster NJ
• MDR Report Key: 9266128
• MDR Text Key: 164880118
• Report Number: MW5090815
• 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: 10/24/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 73