MDR event

Additional Manufacturer Narrative

WHEN THE STAFF REMOVED THE MACHINE FOR SVC, THEY FOUND WATER UNDER IT THAT HAD LEAKED INTO THE REVERSE OSMOSIS (RO) LOOP SYSTEM WATER BOX. SINCE THE WATER BOX HAPPENED TO BE AT A SLIGHT DECLINE, THE STAFF DID NOT NOTICE THE LEAK UNTIL THE MACHINE WAS PULLED. FACILITY BIOMEDICAL TECH RECEIVED THE MACHINE FOR SVC AND FOUND THAT THE TUBING FROM THE PI TRANSDUCER TO THE EV1 HAD A SMALL SPLIT IN IT. SINCE THIS PATH IS PART OF THE MASS BALANCE SYSTEM, IT AFFECTED THE AMOUNT OF WEIGHT REMOVED FROM THE PT. FACILITY BIOMEDICAL TECH STATED THAT THE SPLIT IN THE SILICONE TUBING WAS SO SMALL THAT IT WAS UNLIKELY THAT THE PRESSURES IN THE MASS BALANCE SYSTEM VARIED ENOUGH TO ELICIT AN ALARM. FACILITY BIOMEDICAL TECH CONTACTED GAMBRO'S TECHNICAL ASSIST SVC (TAS), WHO TOLD HIM TO SUBSTITUTE THE DEFECTIVE PIECE OF TUBING WITH ANOTHER PIECE OF TUBING FROM ANOTHER PHOENIX MACHINE AS LONG AS THEY WERE THE SAME DIAMETER SIZE. FACILITY BIOMEDICAL TECH WAS ORIGINALLY UPSET THAT THIS PIECE OF SILICONE TUBING WAS NOT OFFERED BY GRP AS A SPARE PART. ACTUALLY, THIS PARTICULAR PIECE OF TUBING IS AUTOMATICALLY REPLACED WITH THE 3.35 SOFTWARE UPGRADE. THE MACHINE HAS BEEN BACK IN SERVICE SINCE 2008, AND THE STAFF HAS NO PROBLEMS WITH ANY TYPE OF ERRONEOUS FLUID REMOVAL. FACILITY BIOMEDICAL TECH DID NOT REQUEST A GAMBRO TECHNICAL SVC (GTS) REP TO SVC THE MACHINE AS HE FEELS CONFIDENT THAT EVERYTHING IS WORKING ACCORDING TO MFR'S SPECS.