Description of Event or Problem · 1
A HEALTHCARE PROFESSIONAL AT A USER FACILITY REPORTED: ON (B)(6) 2014, A MALE UNDERWENT A CARDIAC PET (POSITRON EMISSION TOMOGRAPHY) SCAN FOR AN UNREPORTED INDICATION. CARDIOGEN-82 (RUBIDIUM RB 82 GENERATOR) WAS THE MEDICINAL PRODUCT USED FOR THIS PROCEDURE WITH BRACCO'S PT ADMINISTRATION SET FOR USE WITH CARDIOGEN-82 INFUSION SYSTEM. NO PT MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR KNOWN ALLERGIES WERE REPORTED. DURING THE FIRST, OR REST PHASE OF THE IMAGING STUDY, A BACK FLOW OF BLOOD FROM A 20 GAUGE IV (PORT) WAS NOTICED THAT EXTENDED PAST THE PT FILTER IN THE BRACCO CARDIOGEN-82. THE PT ADMINISTRATION SET FOR USE WITH CARDIOGEN-82 INFUSION SYSTEM IS A SINGLE USE, STERILE ADMINISTRATION LINE (105 CM LINE CONSISTING OF A FEMALE LUER LOCK, A 0.22 MICRON STERILE GRADE FILTER, A ONE WAY VALVE FOR BACK FLOW PREVENTION AND A MALE LUER LOCK). IT IS CONNECTED AT ONE END TO THE LINE SUPPLYING THE NUCLEAR MEDICINE AGENT, RB-82, FOR THE IMAGING STUDY AND AT THE OTHER END, REFERRED TO AS THE PT PORT (A 20 GAUGE IV NEEDLE WITH AN APPROXIMATELY 15 CM INCH TUBING LINE AND FEMALE LUER LOCK. IT IS A NON-BRACCO PRODUCT). THIS CASE REFERS TO A PT WHO UNDERWENT CARDIAC PT SCAN FOR AN UNK REASON AND EXPERIENCED BACK FLOW OF BLOOD IN THE ADMINISTRATIVE LINES DURING THE RESTING PHASE OF THE SCAN. THE BACK FLOW OF BLOOD WAS NOTICED FROM THE PERIPHERAL IV SITE THROUGH THE PORT. BLOOD APPEARED TO EXTEND INTO THE MALE LUER LOCK AND FILTER HOUSING OF THE PT ADMIN SET. THE NON-BRACCO PT TUBING SET (PORT) WAS CONNECTED TO BRACCO'S PT ADMINISTRATION SET VIA THE PT ADMINISTRATION SET. BLOOD APPEARED TO BE LEAKING BEFORE AND AFTER THE FILTER IN THE PT ADMINISTRATION SET. THE PT DID NOT EXPERIENCE ANY ADVERSE EVENT AS A RESULT OF THIS APPARENT LEAKAGE. THE STUDY WAS CONTINUED AND THE PT WAS ADMINISTRATED LEXISCAN (REGADENOSON) AS THE CARDIAC STRESS AGENT FOR THE STRESS PORTION OF THE STUDY. LEXISCAN WAS ADMINISTRATED THROUGH THE SAME PORT. A SECOND DOSE OF RB-82 WAS ADMINISTERED TO THE PT USING THE SAME PT ADMINISTRATION SET AND PORT. NO ISSUES OR BACK FLOW OF BLOOD WAS OBSERVED ON THIS STRESS STUDY. AFTER THE STUDY, THE PT ADMINISTRATION SET WAS REMOVED AND FLUSHED; NO LEAKING WAS OBSERVED. THE CARDIOGEN-82 INFUSION SYSTEM PRINT-OUT OF THE ADMINISTRATION INDICATED NORMAL INFUSION ON BOTH REST AND STRESS INJECTIONS. THE PRINT-OUT FOR THE REST PHASE RECORDED THAT THE PT WAS ADMINISTERED 35.0 MCI (1295 MBG) IN 13 ML. THE SECOND DOSE, THE STRESS DOSE, WAS RECORDED AS 35.1 MCI (1298.7MBG) IN 13 ML. THE PT ADMINISTRATION SET WAS RETAINED BY THE FACILITY AND WILL BE SENT BACK TO BRACCO FOR EVALUATION. THE STAFF REPORTED THERE WERE NO SAFETY CONCERNS AND NO FOLLOW-UP WAS MADE WITH THE PT. WORLDWIDE (B)(4).