Description of Event or Problem · 1
AN ELECTRONIC REPORT WAS RECEIVED FROM A HEMODIALYSIS USER FACILITY WHO REPORTED A POSSIBLE DIALYZER REACTION. THE INITIAL REPORTER WAS CONTACTED AND ADDITIONAL VERBAL INFORMATION WAS RECEIVED RELATED TO THIS PATIENT EVENT. IT WAS LEARNED THIS EVENT OCCURRED IN 2006, AND THAT HIS PATIENT HAD "BEEN ONE E-BEAM FOR A FEW MONTHS". ALSO, THE RN STATED THIS ONLY HAPPENS AFTER SALINE IS INFUSED AND THE BP DROPS. FOR THIS EVENT, THE RN REPORTED A "SEVERE" RESPONSE. THE PATIENT RESPIRATORY ARRESTED. THE STAFF GAVE LOTS OF STERNAL RUB. ACCORDING TO THE RN, A PULSE WAS PRESENT. AGONAL BREATHING WAS NOTED BY THE STAFF. THE STAFF KEP STIMULATING THE PATIENT. FOR THIS EVENT, THE STAFF REINFUSED THE PATIENT'S BLOOD AND TX DISCONTINUED. THE PATIENT WAS THEN TRANSFERRED TO THE HOSPITAL WHERE A CARDIAC WORKUP WAS ORDERED. THERE IS NO SAMPLE AVAILABLE AND THE LOT NUMBER IS NOT KNOWN. A REQUEST FOR TREATMENT SHEETS AND OTHER CLINICAL DATA CONCERNING THIS EVENT AS WELL AS ADDITIONAL CLINICAL INFORMATION ON THIS PATIENT WAS REQUESTED FROM THIS RN ON 4 SEPARATE OCCASIONS. TO DATE, A VERBAL RESPONSE WAS GIVEN INDICATING THAT ALL THE REQUESTED INFORMATION WOULD BE FORWARDED. TO DATE, NO ADDITIONAL CLINICAL INFORMATION HAS BEEN RECEIVED IN ORDER TO FULLY EVALUATE THIS PRODUCT COMPLAINT AND EVENT THAT OCCURRED TO THIS PATIENT. THIS PATIENT IS REPORTEDLY FINE WITH NO FURTHER ILL EFFECT RELATED TO THIS EVENT. THE PATIENT CURRENTLY RECEIVES HEMODIALYSIS WITH USE OF THE 180NR OPTIFLUX DIALYZER. THE PATIENT HAS A GRAFT FOR AN ACCESS FOR HEMODIALYSIS. THIS PATIENT IS ALSO A DNR STATUS AND RN STATED STAFF WOULD HAVE GIVEN MORE AGGRESSIVE INTERVENTIONS.