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Description of Event or Problem

PATIENT HAD BLED OUT OF AT LEAST 1.5 LITERS OF BLOOD FROM A LEAKING VENOUS CONNECTION THAT HAD BECOME SLIGHTLY DISCONNECTED. FURTHER INVESTIGATION FOUND THAT PATIENT HAD BEEN PLACED ON THEIR BACK. PATIENT'S WIFE HAD COVERED UP THEIR ACCESS SITE, AND WHEN THE VENOUS PRESSURE ALARM CONDITION WAS RESET THERE WAS NOT A CONFIRMATION OF THE VENOUS PRESSURE BY STAFF. APPARENTLY, THE ALARM CONDITION WAS RESET AT AN UNKNOWN PRESSURE. MACHINE CONTINUES TO OPERATE AT THIS UNKNOWN PRESSURE ONCE RESET WITHOUT ANY FURTHER NOTIFICATION TO OPERATOR. PATIENT'S WIFE CALLED ATTENTION TO THE PATIENT. THE TREATMENT WAS TERMINATED. EMS WAS ACTIVATED AND THE PATIENT WAS MOVED TO THE FLOOR. ONE AND HALF LITERS OF NORMAL SALINE WAS PUSHED AND CPR WAS STARTED AT THE SAME TIME. WITHIN FOUR COMPRESSIONS THE PATIENT BECAME RESPONSIVE. AT THIS POINT THE ER STAFF FROM THE HOSPITAL RESPONDED AND TRANSPORTED THE PATIENT TO THE HOSPITAL ER FOR FURTHER EVALUATION AND CARE. THE MACHINE OPERATION WAS TESTED AND APPEARED TO OPERATE NORMALLY. A CALL WAS PLACED TO FRESENIUS MEDICAL CARE NORTH AMERICA TO REPORT THE PROBLEM. FURTHER FOLLOW-UP WILL BE REPORTED TO MEDWATCH. SPOKE WITH TECHNICAL ASSISTANCE TO FURTHER EVALUATE TESTING METHODS. MACHINE DOES HAVE A BLOOD SENSOR THAT SHOULD GIVE AN ALARM CONDITION WHEN AT A ZERO PRESSURE. THIS SENSOR WAS NOT TESTED AT THE TIME OF INCIDENT. ON ANOTHER DATE I WAS CALLED TO THE FACILITY AND HAD THE CHARGE NURSE TEST THIS SENSOR WITH A ZERO PRESSURE, AND IT APPEARED TO STILL HAVE ALMOST A TWENTY SECOND DELAY BEFORE THE VENOUS CLAMP ENGAGED AND THE BLOOD PUMP STOPPED.====================== MANUFACTURER RESPONSE FOR DIALYSIS DELIVERY SYSTEM, (BRAND NOT PROVIDED)======================FURTHER FOLLOW-UP WILL BE REPORTED TO MEDWATCH.