THERANOVA

Description of Event or Problem

IT WAS REPORTED THAT DURING TREATMENT WITH AN UNSPECIFIED THERANOVA DIALYZER, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND CHEST PAIN. IT WAS FURTHER REPORTED THAT THIS WAS THE FIRST TIME THE PATIENT HAD USED A THERANOVA DIALYZER. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ACCORDING TO THE REPORTER, THE ¿SYMPTOMS RESOLVING AFTER ENDING THERAPY¿. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

A2: AGE AT TIME OF EVENT: REPORTED AS "ADULT". THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B3, B5, D2A, D2B, D4, G4, H4, H6, AND H11. B5: UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAROXYSMAL COUGHING, BACK PAIN, AND CYANOSIS TO LIPS AND ORAL MUCOUS MEMBRANES. THE PATIENT WAS TRANSPORTED FOR EVALUATION VIA EMS (EMERGENCY MEDICAL SERVICES). IT WAS REPORTED THAT THE PATIENT RECEIVED "MEDICAL TREATMENT ON DIALYSIS". H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.