inforMED
InjuryLNR

THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Received Jun 22, 2018 · Event occurred Jan 7, 2018

Report MW5078017 · MDR key 7633698

Device

Generic name

System, Photopheresis

Lot number

051717-16

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

23 YR

  • Pulmonary Embolism
  • Dyspnea
  • Pulmonary Embolism
  • Dyspnea

Narrative

Description of Event or Problem

PATIENT DEVELOPED SHORTNESS OF BREATH ON (B)(6) 2018 AND WAS DIAGNOSED WITH A PULMONARY EMBOLISM ON (B)(6) 2018. THIS WAS AFTER THE PATIENT RECEIVED PHOTOPHERESIS ON (B)(6) 2018. PATIENT HAS BEEN RECEIVING PHOTOPHERESIS FOR GVHD TWICE WEEKLY FOR A TOTAL OF 8 TREATMENTS, THE LAST OF WHICH WAS ON (B)(6) 2018.