HEALTHCARE PROFESSIONAL REPORTED EXCESSIVE BLEEDING WHILE USING HEMOCHRON SIGNATURE ELITE AND ACT+ SYSTEM TO MONITOR ANTICOAGULATION STATUS USING INTRAVENOUS HEPARIN DURING A PROCEDURE. AN (B)(6) KG PT OF UNSPECIFIED AGE AND GENDER WAS UNDERGOING A VASCULAR PROCEDURE ON AN UNSPECIFIED LEG. OVER THE COURSE OF THE PROCEDURE THAT LASTED MORE THAN 3 HRS, ACT+ TEST RESULTS INCREASED ACCORDINGLY DURING INCREMENTAL HEPARIN DOSING. NEAR THE END OF THE PROCEDURE EXCESSIVE BLEEDING OCCURRED, INITIALLY TREATED WITH FRESH FROZEN PLASMA AND FINALLY PROTAMINE TO REVERSE THE EFFECTS OF HEPARIN. THE ACT RESULT FELL TO NORMAL LEVELS AND BLEEDING WAS CONTROLLED. NO SERIOUS ADVERSE EVENTS OR OTHER MEDICAL COMPLICATIONS WERE REPORTED. BOTH ELECTRONIC AND LIQUID QUALITY CONTROL TESTING PASSED PRIOR TO THE PROCEDURE. SYSTEM MALFUNCTION IS NOT SUSPECTED.
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Patient 1
THIS MDR SUBMITTED ON 06/10/2015 REFERENCES ITC COMPLAINT #(B)(4). THE ASSOCIATED HOMOCHRON SIGNATURE ELITE INSTRUMENT USED DURING THE PROCEDURE IS REFERENCED BY ITC COMPLAINT #(B)(4). THE MOST LIKELY CAUSE FOR THIS PATIENT'S BLEEDING WAS THE ADMINISTRATION OF AN EXCESSIVE AMOUNT OF HEPARIN. THIS MAY HAVE BEEN COMPOUNDED BY AN UNDOCUMENTED ANTI-THROMBIN-III DEFICIENCY. THE USE OF THIS JACT+ TEST, WHICH IS NOT OPTIMIZED FOR LOW HEPARIN CONCENTRATIONS, MAY HAVE CONTRIBUTED TO HOW THE ANTICOAGULATION MANAGEMENT WAS CONDUCTED DURING THE PROCEDURE. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
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Patient 1
MDR FOLLOW-UP #1 REFERENCES (B)(4), AND SUMMARIZES THE RESULTS OF LSR-030 THAT EVALUATED A DEVICE FROM THE SAME LOT OF JACT+ CUVETTES.