ECMO FMEA Archives

• Narrative 1: ECMO MEA A1 Failure of Blood Flow Safety 10.9.2018
• Narrative 2: ECMO FMEA B1 No Pressure Alarm Function 10.9.2018
• Narrative 3: ECMO FMEA C1 Failure Blood Dripping on the Pump or Floor 10.9.2018

CPB FMEA Archives

• FMEA Archive File #1: Right heart air embolus from an unknown source upon initiation of CPB
• FMEA Archive File #2: C pump failure to initiate bypass
• FMEA Archive File #3: Heat Exchanger Leak in the Oxygenator or Cardioplegia Heat Exchanger
• FMEA Archive File #4: Perfusionist skills decay
• FMEA Archive File #5: Inadequate Cerebral Oxygenation as Indicated by Cerebral Oximetry
• FMEA Archive File #6: Cardiotomy/venous reservoir over pressurization
• FMEA Archive File #7: Clotted circuit
• FMEA Archive File #8: Inadequate venous drainage caused by non-anatomical obstruction 
• FMEA Archive File #9: Hemodynamic instability due to the presence of hypertrophic cardiomyopathy (HCM), idiopathic hypertrophic subaortic stenosis (IHSS) and its variants
• FMEA Archive File #10: Roller pump failure to turn
• FMEA Archive File #11: Failure to take proper precautions for the sickle cell disease (SCD), sickle cell trait (SCT) or thalassemia patient undergoing CPB to prevent post-op sickle cells
• FMEA Archive File #12: FAILURE: Hemorrhage secondary to redo sternotomy
• FMEA Archive File #13: Failure to monitor and maintain the appropriate fluid balance during cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF)
• FMEA Archive File #14: Sweep gas circuit (SGC) failure
• FMEA Archive File #15: Acute, iatrogenic ascending dissection of the aorta (AO) after initiating cardiopulmonary bypass (CPB)
• FMEA Archive File #16: Perfusionist’s inability to deal with fear in a stressful situation
• FMEA Archive File #17: Transfusion error failure
• FMEA Archive File #18: Heater/cooler contamination
• FMEA Archive File #19: Cephalic artery hyperperfusion
• FMEA Archive File #20: Failure to prevent hypotension following CPB initiation, Level 1
• FMEA Archive File #21: Failure to Preven Hypotension on CPB Following Phenylephrine and/or Norepinephrine Administration: Level II
• FMEA Archive File #22: Failure to Prevent Hypotension Following CPB Initiation, Level III
• FMEA Archive File #23: Failure: Rupture of the Coronary Sinus (CS) with Retrograde Cardioplegia (RCP)
• FMEA Archive File #24: Defoamer Failure
• FMEA Archive File #25: Mismatch of Roller Pump Read Out and Blood Flow
• FMEA Archive File #26: Antiphospholipid Syndrome
• FMEA Archive File #27: Hardshell Venous Reservoir Emptying
• FMEA Archive File #28: Blood Line Pull-off or Blow-off
• FMEA Archive #29: Hyperkalemia
• FMEA Archive #30: High Pressure Excursion
• FMEA Archive #31: Human Fatigue Failure
• FMEA Archive #32: Inadequate Venous Return Caused by Abnormal Anatomy
• FMEA Archive #33: Failure to Recognize the Presence of Major Aortic to Pulmonary Collateral Arteries (MAPCAs)
• FMEA Archive #34: Failure to Wean from CPB Due to Acute Pulmonary Hypertension (APH) Crisis
• FMEA Archive #35: Failure to Prevent Post Pump Chorea from Developing After CPB Using Deep Hypothermic Circulatory Arrest (DHCA)
• FMEA Archive #36: Accidental, Non-drowning Hypothermia 
• FMEA #37: Repairable Circuit Component Failure
• FMEA #38: Bicarbonate Imbalance
• FMEA #39: Impaired Perfusionist
• FMEA #40: Calcium Regulation
• FMEA #41 Checklist Failure 
• FMEA #42 Spallation 
• FMEA #43 Gross Blood to the Face
• FMEA #44 Heater Cooler Hose Failure 
• FMEA #45 Failure to Communicate
• FMEA #46 Failure to reinstitute CPB emergently 
• FMEA #47 Failure of integrated cardiotomy filter due to unexplained  obstruction. 
• FMEA #48 Failure to prevent osmotic demyelination syndrome during CPB in patients with chronic severe hyponatremia
• Complete CPB FMEA Archive