Description of Event or Problem · 0
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THERE WAS A HIGH-PRESSURE EXCURSION EXPERIENCED ON THE MEMBRANE CAUSING LOW FLOW TO PATIENT WHICH RESULTED IN THE PATIENT'S DEATH. ON (B)(6), THE PATIENT WAS PLACED ON VENOARTERIAL (VA) ECMO FOR AN ANTERIOR ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AT RCH. THE PATIENT EXPERIENCED A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST. THE TOTAL DOWNTIME WAS 40 MINUTES. THE PATIENT HAD A LEFT ANTERIOR DESCENDING (LAD) BALLOON ANGIOPLASTY. ON (B)(6), THE PATIENT WAS TRANSFERRED TO SPH. ON (B)(6), THEY ATTEMPTED TO WEAN AND IT FAILED. ON (B)(6), THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) FOR A HEARTMATE 3 (HM3) INSERT. THE PATIENT BECAME ACIDOTIC AND THIS LED TO RIGHT VENTRICULAR (RV) FAILURE. A RIGHT VENTRICULAR ASSIST DEVICE (RVAD) WAS INSERTED; HOWEVER, THE PATIENT THEN BECAME HYPOXIC. A RVAD AND OXYGENATOR WERE INSERTED. THE PATIENT WAS OFF HEPARIN SINCE (B)(6) AT 8.40A.M. THE RVAD WAS CHATTERING WITH A FLOW OF 2.0 LPM AND THE HM3 WAS FLOWING AT 2.9 LPM. AT 16.04P.M, THE FLOW WAS INCREASED TO 2.5 LPM. THE REVOLUTIONS PER MINUTE (RPM) WAS AT 2000. THE PRE-OXYGENATOR PRESSURE WAS 175 MMHG AND THE POST-OXYGENATOR PRESSURE WAS 145 MMHG. THE RVAD FRACTION OF INSPIRED OXYGEN (FIO2) INCREASED FROM 60% TO 70%. THE HM3 FLOW WAS AT 3.1 LPM. AT 16.05P.M, THE CHATTER AND RVAD FLOWS DROPPED TO 2.0-2.1 LPM. THEY REVIEWED THE CHART AND NOTICED THE INCREASE IN DELTA P. THEY RE-ZEROED THE PRE-MEMBRANE AND POST-MEMBRANE PRESSURE TRANSDUCERS WITH NO CHANGE IN PRESSURE. AT 16.16P.M, THE DELTA P'S WERE IN THE SIXTIES. THE PRE-OXYGENATOR PRESSURE WAS AT 178MMHG AND THE POST-OXYGENATOR PRESSURE WAS 118MMHG. AT 16.18P.M, THE DELTA P WAS 80 AND THE RVAD FLOW WAS 1.8 LPM. THE HM3 HAD A LOW FLOW ALARM. AT 16.20P.M, THEY CALLED THE CUSTOMER BACK FOR A CIRCUIT CHANGE. THE RPM INCREASED TO 2300 WITH NO CHATTER. AT 16.21P.M, THE PRE-OXYGENATOR PRESSURE WAS 280 MMHG AND THE POST-OXYGENATOR PRESSURE WAS 78MMHG. THE FLOW WAS 1.4 LPM WITH NO CHATTER. THE PRE-OXYGENATOR PRESSURE WAS IN THE LOW 300'S. THE RVAD FLOW WAS AT 0.8 LPM. THEY PREPPED THE LINES AND EQUIPMENT FOR A CIRCUIT CHANGE. THE RVAD FLOW WAS AT 0.6 LPM. THE PHYSICIAN (DR. (B)(6)) ENTERED AND INFORMED THE TEAM TO NOT TO CHANGE CIRCUIT AS PER THE OTHER PHYSICIAN (DR. (B)(6) DUE TO FUTILITY. AT 16.28P.M, THE RVAD AND ECMO WERE TURNED OFF AND THE PATIENT DIED. THERE WERE MULTIPLE TRANSFUSIONS ADMINISTRATED TO THE PATIENT FROM 15.25P.M TILL 1P.M. THE NEXT DAY. THE PATIENT WAS GIVEN 40ML OF PROTHROMBIN COMPLEX 6 TIMES, DIFFERENT AMOUNTS OF PLATELETS AT MULTIPLE TIMES, 50ML FIBRINOGEN TWICE, 180 ML PLATELETS, MULTIPLE MLS OF (RED BLOOD CELLS) RBC AND 500/250ML OF ALBUMIN 5% MULTIPLE TIMES. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) INCREASED TO 3.3, THEIR PARTIAL THROMBOPLASTIN TIME (PTT) WAS GREATER THAN 140 AND RECORDED AT 135 AND THEIR PLATELET COUNT WAS 25 AT 14.26P.M ON (B)(6). THERE FIBRINOGEN WAS LESS THAN 0.6 AT 19.48P.M ON (B)(6). MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT WHEN THE PATIENT ARRIVED AT ST (B)(6) HOSPITAL ON (B)(6), THE PATIENT WAS ON THE MAQUET QUADROX OXYGENATOR. THE PATIENT WAS RECEIVED FROM RCH. THE FIRST NAUTILUS OXYGENATOR WAS USED ON (B)(6) 2024. TWO NAUTILUS OXYGENATORS WERE USED. ON (B)(6) 2024, THE PATIENT WAS PLACED ON VA ECMO WITH A QUADROX OXYGENATOR FOR 10 DAYS. THERE WAS NO OXYGENATOR CHANGE INDICATED ON TRANSFER SHEET AT THIS POINT. ON (B)(6) 2024, THE PATIENT WAS PLACED ON VA ECMO WITH A NEW CIRCUIT AND NAUTILUS OXYGENATOR FOR 3 DAYS/70 HOURS. ON (B)(6) 2024, THE PATIENT WAS ON CARDIOPULMONARY BYPASS (CPB) WHILE USING AN AFFINITY FUSION OXYGENATOR FOR 123 MINUTES. ON (B)(6) 2024, THE PATIENT WAS ON RVAD WITH A NEW CIRCUIT AND NO OXYGENATOR FOR 54 MINUTES. ON (B)(6) 2024, THE PATIENT WAS ON RVAD WITH A NEW CIRCUIT AND NAUTILUS OXYGENATOR FOR 1 DAY/21 HOURS. THE LAST OXYGENATOR USED WAS THE COMPLAINT DEVICE. THERE WAS NO ANTICOAGULANTS, OTHER THAN HEPARIN, USED FOR THE PATIENT. HEPARIN WAS DISCONTINUED ON (B)(6) 2024 AT 8:40A.M. THE RVAD PLUS OXYGENATOR INITIATED ON (B)(6) 2024 AT 7:04 P.M. THERE WAS NO CLOTS VISUALIZED ON THE COMPLAINT DEVICE. THERE WAS CLOTS VISUALIZED ON THE PRE-MEMBRANE OXYGENATOR AND ¼" DISTAL LIMB PERFUSION LINE ON THE VA ECMO CIRCUIT WHICH WAS INITIATED ON (B)(6) 2024. THERE WAS NO CIRCUIT COMPONENTS CHANGED OUT ON (B)(6) 2024 DUE TO PATIENT FUTILITY AS PER SURGEON. THE PATIENT'S HEMATOCRIT AT INITIATION OF ECMO AND AT THE ONSET OF THE TIME THE EVENT WAS FIRST SUSPECTED ON (B)(6) 2024 AT 7.04P.M. WAS 22.9L/L (HCT). HEMOGLOBIN (HGB) WAS 75G/DL AT 6.28P.M. THE PATIENT'S HEMATOCRIT WAS 28L/L AND HGB WAS 95G/DL AT 7.48P.M. ONSET OF EVENT FIRST SUSPECTED, ON (B)(6) 2024 AT 4.05-4.10 P.M, THE PATIENT'S HEMATOCRIT WAS 34L/L AND HGB WAS 115G/DL. THERE WAS NO MENTION OF A DELTA P INCREASE DURING HANDOVER FOR BREAK RELIEF AT 3.52P.M. THE LAST ACT VALUE WAS RECORDED AT 162S ON (B)(6) 2024 AT 3.46P.M. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT (B)(6) HOSPITAL.