Additional Manufacturer Narrative · 1
THE SORIN S3 ROLLER PUMP IS MANUFACTURED BY SORIN GROUP AND DISTRIBUTED BY SORIN GROUP USA, INC. THE MEDWATCH REPORT INDICATED THAT DURING THE RE-WARMING PHASE, SURGERY WAS INTERRUPTED BY A PUMP FAILURE. THE PERFUSIONIST BEGAN HAND-CRANKING THE PUMP HEAD TO MAINTAIN PT SUPPORT. THE PUMP WAS POWER CYCLED OFF AND ON AND THEN PERFORMED NORMALLY. CARDIOPULMONARY BYPASS WAS RE-ESTABLISHED. THE CLINICAL COORDINATOR STATED THAT THERE WAS NO PT INJURY DUE TO THE INCIDENT. THE SORIN GROUP USA TECHNICAL SUPPORT SPECIALIST WAS CONTACTED AND OFFERED TO EVALUATE THE PUMP. THE HOSP BIOMEDICAL ENGINEER, WHO HAD BEEN PREVIOUSLY TRAINED BY SORIN GROUP USA SERVICE. DECLINED THE OFFER AND CHOSE TO PERFORM MULTIPLE TESTS ON THE PUMP AT THE FACILITY. THE PUMP WAS RUN UNDER SIMULATED CONDITIONS FOR AN EXTENDED PERIOD OF TIME. THE PROBLEM WAS DUPLICATED. THE PUMP WAS PLACED BACK INTO SERVICE AS A SUCKER PUMP. NO FURTHER ACTION IS REQUIRED.