HMO 71000-J#QUADROX-I ADULT + FILTER

Description of Event or Problem

THE PRODUCT WAS USED FOR EMERGENCY SURGERY ON (B)(6) 2013. JUST AFTER EXTRACORPOREAL CIRCULATION STARTED, BLOOD LEAKAGE WAS NOTED FROM THE DIALYSIS LOCK AND VALVE. ALTHOUGH THE CAP OF THE DIALYSIS LOCK WAS FASTENED AGAIN TIGHTLY, BLOOD LEAKAGE WAS STILL OBSERVED. THE SURGERY WAS CONTINUED WITH BLOOD LEAKING. AFTERWARD, THE EXTRACORPOREAL CIRCULATION WAS COMPLETED. CIRCUIT INNER PRESSURE DURING PRIMING PROCEDURE WAS 100MMHG. CIRCUIT INNER PRESSURE DURING EXTRACORPOREAL CIRCULATION WAS 250-350MMHG. NO PATIENT INJURY WAS REPORTED. REF.: (B)(4).

Additional Manufacturer Narrative

(B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE SAMPLE HAS NOT BEEN RECEIVED YET. UNTIL NOW IT IS UNCLEAR IF THE DEVICE IS AVAILABLE FOR AN INVESTIGATION. REQUEST FOR THE DEVICE IS PENDING. IF THE SAMPLE IS AVAILABLE THE INVESTIGATION WILL BE INITIATED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF FURTHER INFORMATION BECOMES AVAILABLE.