SINCE MANUFACTURE AND RELEASE OF THE DEVICE IN 2016, IT HAS BEEN SERVICED AND MAINTAINED AT THE CUSTOMER SITE BY THEIR TRAINED AND QUALIFIED INTERNAL FACILITY BIOMEDICAL ENGINEERS. SITE RECORDS FOR SERVICING, MAINTENANCE AND CALIBRATION WERE NOT AVAILABLE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND CONFIRMED THE DEVICE MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. FOLLOWING THIS EVENT, THE CYCLER WAS SENT TO AND RECEIVED BY THE NXSTAGE SERVICE AND MANUFACTURING SITE FOR EVALUATION. TESTING SHOWED THAT THE ULTRAFILTRATION PUMP REQUIRED CALIBRATION, AFTER WHICH THE DEVICE PASSED ALL TESTING. WHEN IN CRITICAL CARE, THE PATIENT?S HEMODYNAMIC, FLUID, AND ELECTROLYTE BALANCE MUST BE MONITORED REGULARLY, AND THEIR TOTAL FLUID BALANCE MUST ACCOUNT FOR WEIGHING TECHNIQUE, SCALE ACCURACY, FLUID CONSUMPTION AND OUTPUT. PATIENTS IN CRITICAL CARE HAVE MULTIPLE POTENTIAL SOURCES OF FLUID INPUT AS PART OF THEIR CARE PLAN WHICH IMPACT THEIR FLUID BALANCE STATUS. THE USER GUIDE STATES THAT ALL TREATMENTS MUST BE ADMINISTERED UNDER A PHYSICIAN?S PRESCRIPTION. A TRAINED AND QUALIFIED PERSON MUST OBSERVE ALL TREATMENTS TO MONITOR VITAL SIGNS IN RESPONSE TO THERAPY, THEIR GENERAL WELL-BEING AND PHYSICAL STATUS, AND TO PROMPTLY RESPOND TO HARMFUL CONDITIONS THAT MAY OCCUR. UDI #: (B)(4).
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Patient 1
A REPORT WAS RECEIVED ON 06 NOV 2019 FROM A BIOMEDICAL ENGINEER REGARDING AN ADULT PATIENT IN CRITICAL CARE FOR PULMONARY EDEMA, PERICARDIAL EFFUSION, AND GENERALIZED EDEMA WHO EXPERIENCED WORSENED GENERALIZED EDEMA AND WEIGHT INCREASE DURING CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) TREATMENTS USING THE NXSTAGE SYSTEM ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION WAS RECEIVED ON 24 FEB 2020 FROM THE NURSE STATING THE PATIENT WAS NOT RESPONDING AS EXPECTED AND HAD WORSENED GENERALIZED EDEMA AFTER TREATING ON THE NXSTAGE DEVICE FOR MULTIPLE UNSPECIFIED DAYS. DESPITE REQUESTS, NO INFORMATION REGARDING RELATED MEDICAL INTERVENTION WAS PROVIDED. FLUID BALANCE DETAILS DURING THIS TIME, OUTLINING THE PATIENT?S INTAKE AND OUTPUT, INCLUDING MEDICALLY ADMINISTERED FLUIDS, WERE NOT PROVIDED.