HEMOLUNG RAS

Description of Event or Problem

ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT OF A PATIENT EXPERIENCING HYPOTHERMIA DURING HEMOLUNG THERAPY. THERAPY WAS STILL PROVIDED AS INTENDED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT PROVIDED. ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS AND CATHETER. THE INCIDENT OCCURRED IN (B)(6). THROUGH REVIEW OF THE FINAL CLINICAL STUDY ADVERSE EVENT LISTINGS, IT WAS REPORTED THAT A PATIENT EXPERIENCED HYPOTHERMIA. AS NO FURTHER NOTIFICATION WAS RECEIVED REGARDING THIS ADVERSE EVENT, NO FURTHER INFORMATION IS AVAILABLE. NO CAPA WAS OPENED BECAUSE OF THIS EVENT. HYPOTHERMIA IS A KNOWN POTENTIAL COMPLICATION THAT CAN OCCUR DURING EXTRACORPOREAL THERAPY. ALUNG TECHNOLOGIES, INC. WILL CONTINUE TO MONITOR ANY ISSUES AS THEY ARE REPORTED. THIS MDR IS BEING FILED IN RESPONSE TO A RETROSPECTIVE VIEW OF ALL ALUNG TECHNOLOGIES, INC. COMPLAINTS, WHICH IDENTIFIED THAT THE REPORTING DECISION FOR THIS COMPLAINT WAS NOT CORRECT. THIS MDR IS BEING FILED RETROSPECTIVELY TO CORRECT THE ERROR IN THE REPORTING DECISION.