HEMOLUNG RAS

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT PROVIDED. ALUNG TECHNOLOGIES, INC. MANUFACTURES THE HEMOLUNG RAS. THE INCIDENT OCCURRED IN MINNEAPOLIS, MINNESOTA. MEDICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER PATIENT INJURY. THERE IS NO ALLEGED DEVICE MALFUNCTION WHICH OCCURRED IN RELATION TO THE REPORTED PATIENT ADVERSE EVENT. THE DATA LOG FROM HEMOLUNG THERAPY HAS BEEN RETRIEVED AND REVIEWED BY BOTH CLINICAL AND SOFTWARE ENGINEERING STAFF. HEMOLUNG THERAPY WAS PROVIDED AS INTENDED. NO CORRECTIVE ACTION WAS INITIATED IN RESPONSE TO THIS EVENT. CARDIAC ARRHYTHMIA IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH USE OF EXTRACORPOREAL THERAPY AND CRITICAL ILLNESS (PATIENT SUFFERED FROM COVID-19 AND RESPIRATORY ACIDOSIS). 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. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DATA LOG REVIEWED.

Description of Event or Problem

ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT OF A PATIENT WHO EXPERIENCED A CARDIAC ARRHYTHMIA DURING SUPPORT WITH A HEMOLUNG RAS CONTROLLER. THE CARDIAC ARRHYTHMIA REQUIRED ONE OR MORE MEDICAL INTERVENTIONS IN ORDER TO PREVENT PERMANENT INJURY.