QUANTUM VENTILATION MODULE

Additional Manufacturer Narrative

AWAITING THE RETURN OF COMPLAINED DEVICE TO CONDUCT THE INVESTIGATION.

Description of Event or Problem

THE USER REPORTED THE FOLLOWING ISSUE, WHICH OCCURRED DURING TWO CONSECUTIVE CARDIAC SURGERY PROCEDURES WHILE USING THE QVM2 VAVD SYSTEM. FIRST CLINICAL CASE: AFTER THE START OF CPB, THE QVM2 WAS NOT ABLE TO REACH AND MAINTAIN THE NEGATIVE PRESSURE VALUE THAT HAD BEEN SET. THE VACUUM PRESSURE CONTINUOUSLY FLUCTUATED. NO LEVEL ALARM WAS ACTIVATED BECAUSE THE VENOUS DRAINAGE STILL PROVIDED ENOUGH BLOOD VOLUME IN THE VENOUS RESERVOIR TO SAFELY MANAGE THE CPB. THE PERFUSIONIST TRIED TO RESTORE NORMAL OPERATION BY SWITCHING THE VACUUM CONTROL OFF AND ON AGAIN, BUT THE PROBLEM REMAINED. SINCE THE VENOUS DRAINAGE WAS STILL ADEQUATE TO MAINTAIN THE PERFUSION FLOW, CPB WAS CONTINUED WITHOUT USING THE VAVD SYSTEM. SECOND CLINICAL CASE: DURING THE SECOND PROCEDURE, PERFORMED IN THE AFTERNOON, THE SAME ISSUE OCCURRED AGAIN. AT APPROXIMATELY 15:27, THE QVM2 CONTINUOUSLY FLUCTUATED AND WAS UNABLE TO MAINTAIN THE NEGATIVE PRESSURE AT THE SET VALUE. DURING THAT PHASE, THE PRESSURE MONITORED AT THE VENOUS RESERVOIR (P VAVD) ALSO SHOWED CONTINUOUS FLUCTUATIONS. ALTHOUGH THE VENOUS DRAINAGE WAS SUFFICIENT TO MAINTAIN THE PERFUSION FLOW, IT WAS NOT ENOUGH TO ACHIEVE COMPLETE CARDIAC DECOMPRESSION. THE PERFUSIONIST TRIED CHANGING THE NEGATIVE PRESSURE SETTING AND THEN SWITCHED THE VACUUM CONTROL OFF AND ON AGAIN, BUT THE PROBLEM REMAINED UNCHANGED. BECAUSE THE HEART COULD NOT BE ADEQUATELY DECOMPRESSED AND THE SURGEONS REPORTED INSUFFICIENT CARDIAC EMPTYING, THE PERFUSIONIST DECIDED TO BYPASS THE QVM2 VAVD SYSTEM AND USE AN EXTERNAL VACUUM SOURCE. THIS IMMEDIATELY RESTORED ADEQUATE VENOUS DRAINAGE, ALLOWED COMPLETE CARDIAC DECOMPRESSION, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.