PRISMA CONTROL UNIT

Additional Manufacturer Narrative

NO PT INJURY REPORTED. THE MACHINE WAS INSPECTED BY GAMBRO TECHNICIAN. THE PRISMA OPERATOR'S MANUAL INFORMS ABOUT THE POSSIBLE INTERACTION BETWEEN AN ELECTRICALLY ISOLATE PERISTALTIC PUMP AND SOME EKG MONITORS. IN FACT, OUR DEVICE PRISMA IS A BF TYPE. THESE PHENOMENA ARE KNOWN IN CLINICAL LITERATURE AND ARE NOT A PECULIARITY OF OUR MACHINE. IT MUST BE REMARKED THAT GOOD CLINICAL PRACTICES, SUCH AS: CORRECT EKG ELECTRODES POSITIONING ON THE PT; ADEQUATE SKIN/ELECTRODES CONTACT TO MINIMIZE ELECTRICAL IMPEDANCE; GOOD QUALITY EKG LEAD WIRES AND ELECTRODES; AND FINALLY, ADEQUATE EKG MONITOR SHIELDING IMPLEMENTED BY THE EKG MFR ARE FUNDAMENTAL ELEMENTS IN MINIMIZING EKG ARTIFACTS IN AN INTENSIVE CARE UNIT ENVIRONMENT. BEING EKG ARTIFACTS, THE RESULT OF DIFFERENT FACTORS, IT IS, THEREFORE, IMPORTANT FOLLOWING THE INDICATIONS INCLUDED IN THE PRISMA OPERATOR'S MANUAL ADDENDUM: NOTE ON THE COMBINED USE OF PRISMA AND THE ECG MONITORING SYSTEM: "OCCASIONAL DISTURBANCES HAVE BEEN REPORTED IN ELECTROCARDIOGRAM (ECG) RECORDING DURING RENAL REPLACEMENT THERAPY WITH THE PRISMA SYSTEM. THESE DISTURBANCES CAN APPEAR AS ARTIFACTS ON THE ECG TRACE AND MAY BE MISINTERPRETED AS ABNORMAL RHYTHM, ARTIAL FLUTTER, ETC. THE ELECTROCARDIOGRAPH CAN DETECT AN ELECTRICAL INTERFERENCE CAUSED BY ROTATION OF THE PRISMA BLOOD PUMP IF ANY ELECTRODE HAS AN INADEQUATE CONTACT IMPEDANCE WITH THE SKIN. THIS KIND OF ARTIFACT DISAPPEARS WHEN THE PRISMA PUMP STOPS. TO MINIMIZE OR AVOID PRISMA INTERFERENCE WITH ECG RECORDING, IT IS RECOMMENDED TO FOLLOW THE ECG SUPPLIER'S INSTRUCTIONS FOR CHRONIC PT MONITORING CAREFULLY REGARDING USE OF SPECIFIC ELECTRODES WITH LOW CONTACT IMPEDANCE, AND CORRECT APPLICATION OF THE ELECTRODES, INCLUDING APPROPRIATE PLACEMENT OF THE N ELECTRODE." MOREOVER, SPECIFIC WARNINGS ON THE PRISMA OPERATOR'S MANUAL, WARNS THE OPERATOR: "IF A CARDIAC DYSRHYTHMIA IS EXHIBITED, PRESS THE STOP SOFTKEY ON THE PRISMA SYSTEM AND REASSESS THE CARDIAC RHYTHM BEFORE TREATING THE PT. TO SIGNIFICANTLY REDUCE THE LIKELIHOOD OF PRODUCING ARTIFACTS, FOLLOW THE INSTRUCTIONS GIVEN IN APPENDIX B/D OF THIS MANUAL."

Description of Event or Problem

THE CUSTOMER REPORTED ARTIFACTS DURING THE EKG MONITORING.