Additional Manufacturer Narrative · 1
NO PT INJURY REPORTED. FACILITY'S BIOMEDICAL TECH STATED THAT HE DID NOT KNOW IF THE REPOSITIONING PROCEDURE WAS DONE OR NOT. HE ALSO DID NOT KNOW WHICH PRESSURE WAS INVOLVED. A GAMBRO TECHNICAL SERVICE (GTS) FIELD REP FOUND THAT THE MACHINE EVENT LOG INDICATED MULTIPLE PERIODIC SELF-TEST FAILURES FOLLOWING FILTER CLOTTING ADVISORIES THAT HAD BEEN PRECEDED BY A BLOOD PUMP PAUSED. THE SERVICE TECH INSPECTED THE MACHINE. HE PERFORMED A SIMULATED RUN TO VERIFY MACHINE FUNCTIONALITY. MACHINE SUCCESSFULLY PASSED PRIME SELF TEST AND SUBSEQUENT PERIODIC SELF TEST. HE RETRICTED TUBING TO CREATE PRESSURE DROP ACROSS FILTER TO SIMULATE CLOTTING. MACHINE GENERATED ALARMS APPRORIATELY. THE SERVICE TECH WAS UNABLE TO DUPLICATE SELF TEST FAILURE. AS A CORRECTIVE ACTION, AN EVAL OF THE PRISMA OPERATOR'S MANUAL TROUBLESHOOTING SECTION (THAT COULD HELP IN IDENTIFYING AND CORRECTING INSTANCES OF INCORRECT PRESSURE READING CAUSED BY AN INCOMPLETE DIAPHRAGM REPOSITIONING IN CASE OF CLOTTING) IS IN PROGRESS. 510(K)# IS K010805