Impella Impella LD AIC Pump SetRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00813502011227), received between Oct 3, 2023 and Nov 30, 2024 — classified as 9 deaths, 37 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (9 reports).

3 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 27, 2023Class IOpen, Classified

   IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

   Z-0980-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Dec 27, 2023Class IIOpen, Classified

   New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

   Z-1074-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

3. Jun 14, 2023Class IOpen, Classified

   There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.

   Z-2113-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT WAS ESCALATED TO AN IMPELLA LD FROM AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED AFTER THE IMPELLA LD WAS WEANED AND EXPLANTED, THE MEDICAL TEAM FOUND A CLOT IN THE GRAFT CONNECTED TO THE AORTA. THERE WERE NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20813698 ↗
• DeathNov 30, 2024Positioning Failure; Restricted Flow rate; Positioning Failure; Restricted Flow rate

  THE COMPLAINANT REPORTED A PATIENT IN POST CARDIOTOMY CARDIOGENIC SHOCK AND WITH LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA LD FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA LD SUPPORT, THE PUMP HAD POSITIONING ISSUES WHICH CAUSED THE PUMP FLOW TO BE <1.0 L/MIN. THE PHYSICIAN REPORTED ISSUES WITH OBTAINING OPTIMAL PLACEMENT OF THE DEVICE, AND COULD NOT CORRECT THE LOW PUMP FLOW WITH REPOSITIONING. THE PHYSICIAN DECIDED TO EXPLANT THE IMPELLA LD, AND REPLACE THE DEVICE WITH AN IMPELLA 5.5. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO PLACE THE IMPELLA 5.5. IT WAS NOTED THAT THE PATIENT'S CARE WAS WITHDRAWN 11 DAYS LATER AND THE PATIENT EXPIRED. THE POSITIONING ISSUES THAT REQUIRED SURGICAL INTERVENTION TO RESOLVE COULD NOT BE EXCLUDED AS A CONTRIBUTING FACTOR WITH THE LIMITED INFORMATION AT HAND, EVEN THOUGH THE PATIENT EXPIRED 11 DAYS LATER.

  Patient problems: Insufficient Information

  MAUDE report 20813695 ↗
• InjuryNov 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN POST CARDIOTOMY CARDIOGENIC SHOCK AND WITH LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA LD FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED WHILE ON IMPELLA LD SUPPORT, THE PATIENT WAS TAKEN TO THE OR FOR EXPLORATORY SURGERY. THE PATIENT HAD SIGNIFICANT OOZING FROM ROOT AND AT VALVE AND HAD CARDIAC TAMPONADE AND THE LEFT VENTRICLE WAS BEING COMPRESSED. A LARGE CLOT WAS REMOVED, AND 1500ML OF VOLUME WAS REMOVED FROM THE CHEST. THE PATIENT WAS TRANSFUSED WITH 2 CELL SAVER, 1 UNIT OF PACKED RED BLOOD CELLS, AND 1 UNIT OF PLATELETS. THE PATIENT HAD BEEN HEPARINIZED FOR IMPELLA USE, HEPARIN WAS DISCONTINUED. THE PATIENT REMAINED ON IMPELLA LD SUPPORT FOLLOWING THE INTERVENTION UNTIL THE PATIENT WAS SUCCESSFULLY WEANED AND EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 20813679 ↗
• DeathNov 30, 2024Increase in Pressure; Increase in Pressure

  US COMPLAINANT REPORTED THE PATIENT WITH UNKNOWN ETHNICITY WAS ON IMPELLA LD FOR HEMODYNAMIC SUPPORT. WHILE ON SUPPORT LOW PURGE FLOW, HIGH PURGE PRESSURE ALARMS, AND BLEEDING WAS NOTED. TPA WAS ADMINISTERED IN THE IMPELLA PURGE DUE TO PURGE ALARMS. HEPARIN WAS REMOVED FROM PURGE DUE TO BLEEDING. IT WAS REPORTED THAT THE PATIENT EXPIRED ON SUPPORT. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20813677 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS ON AN IMPELLA FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED ABDOMINAL COMPARTMENT SYNDROME, CONFIRMED BY A BLADDER PRESSURE OF 22. EXPLORATION OF ABDOMEN WAS PERFORMED, AND 4 LITERS OF BLOOD WAS REMOVED FROM AROUND ABDOMEN. SODIUM BICARBONATE WAS ADDED TO THE PURGE AND HEPARIN WAS WITHHELD. ADDITIONAL INFORMATION NOTED THE PATIENT WAS MADE A DO NOT RESUSCITATE, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20813576 ↗
• InjuryNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION NEEDING AN IMPELLA LD DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED THAT DURING IMPELLA PLACEMENT, THE PATIENT EXPERIENCED BLEEDING COMPLICATIONS DUE TO AN EXTENSIVE PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S AORTA WAS REPATCHED, AND THE CHEST WAS OPEN POST OPERATION. IT WAS STATED THAT SEVEN UNITS OF RED BLOOD CELLS WERE PROVIDED AND HEPARIN WAS REMOVED FROM THE PURGE IN AN EFFORT TO MANAGE THE COMPLICATION. THE PATIENT WAS SUCCESSFULLY WEANED FROM THE IMPELLA AND THE DEVICE EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20813505 ↗
• DeathNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  US COMPLAINANT REPORTED THAT A PATIENT WAS ESCALATED FROM FEMORAL IMPELLA CP AND PERIPHERAL ECMO TO CENTRAL RVAD AND IMPELLA LD. (5.0) IT WAS REPORTED THAT VASCULAR WAS CALLED FOR CUTDOWN OF LEFT GROIN DUE TO ABSENT PULSE IN LEFT FOOT. ADDITIONALLY, PHYSICIAN FOUND DISSECTED FEMORAL ARTERY. ARTERY WAS REPAIRED. IT WAS ALSO NOTED THAT THE PATIENT WAS EVALUATED FOR POSSIBLE ADD OF D5/HEPARIN 6.25 TO CONTROL BLEEDING. THE PATIENT EXPIRED ON SUPPORT. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Ischemia; Vascular Dissection

  MAUDE report 20810883 ↗
• InjuryNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INTERVENTION WAS IMPLANTED WITH AN IMPELLA LD DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE PATIENT WAS OBSERVED TO BE BLEEDING POST CORONARY ARTERY BYPASS GRAFT (CABG). IT WAS STATED THAT THE PATIENT WAS TRANSFUSED 6 UNITS OF BLOOD PRODUCTS IN AN EFFORT TO MANAGE THE COMPLICATION. HOWEVER, THE PATIENT'S BLEEDING WAS PERSISTENT. IT WAS STATED THAT THE MEDICAL STAFF WITHHELD HEPARIN UNTIL THE BLEEDING WAS UNDER CONTROL. WEANING WAS SUCCESSFUL, THE DEVICE WAS EXPLANTED, AND THE PROCEDURAL OUTCOME WAS THE PATIENT SURVIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 20810797 ↗
• InjuryNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INSERTION WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. AT THE END OF SUPPORT, ONCE THE CHEST WAS CLOSED, THE PATIENT HAD SIGNIFICANT BLEEDING. THE PATIENT HAD TO BE REOPENED TWO TIMES, AND THE PHYSICIAN FOUND A BLEEDING SITE AND EMPLOYED SHUNT TO THE RIGHT ARTERY. PATIENT RECEIVED SIX PLATELETS, SIX UNITS' FRESH FROZEN PLASMA, FOUR CRYO, FOUR UNITS RED BLOOD CELLS, 2000 ANTI-INHIBITOR COAGULANT COMPLEX (FIEBA) FULL DOSE FACTOR SEVEN ADMINISTERED IN PROCEDURE DUE TO BLEEDING. NO PERIPHERAL HEPARIN OR DTI RUNNING. IT WAS LATER NOTED THAT THE PATIENT WAS STILL BLEEDING, SO DEXTROSE 5% IN WATER/BICARBONATE RUNNING IN PURGE. PATIENT TAKEN BACK TO CARDIOVASCULAR OPERATING ROOM, EVACUATED 4.5 CM WALL OF CLOT FROM THE MEDIASTINUM. HEMODYNAMICS GREATLY IMPROVED AFTER EVACUATION. THE PATIENT CONTINUED ON SUPPORT UNTIL THE DEVICE WAS SUCCESSFULLY WEANED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20810664 ↗
• InjuryNov 29, 2024Increase in Pressure; Increase in Pressure

  THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA LD DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AS A BRIDGE TO THERAPY. WHILE ON SUPPORT, THE PATIENT EXPERIENCED BLEEDING ISSUES DURING THE CORONARY ARTERY BYPASS GRAFT REQUIRING SIX UNITS OF PACKED RED BLOOD CELLS, 6 UNITS OF FRESH FROZEN PLASMA, AND TWO UNITS OF PLATELETS. IT WAS REPORTED THAT DUE TO HIGH PURGE PRESSURE ISSUES THAT TISSUE PLASMINOGEN ACTIVATOR WAS STARTED RESULTING IN A CLEARED PURGE PATHWAY. THE PATIENT REMAINED ON IMPELLA SUPPORT AND WAS REPORTED TO HAVE SURVIVED A SUCCESSFUL WEANING AND EXPLANT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20810476 ↗
• DeathNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA LD DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE THE PHYSICIAN WAS WASHING OUT THE CHEST, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF), REQUIRING APPROXIMATELY 20 SHOCKS WITH INTERNAL PADDLES THROUGHOUT THE CASE. AFTER THE IMPLANTATION OF THE PROTEK DUO, THE PATIENT DEVELOPED SIGNIFICANT CLOTS IN THE RIGHT VENTRICLE (RV). THE IMPELLA DEVICE WAS REMOVED AT THE BEDSIDE. ADDITIONAL INFORMATION WAS PROVIDED THAT NOTED CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 20798793 ↗
• DeathNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED THAT THE PATIENT WAS BEING PLACED ON IMPELLA 5.0 FOR HEMODYNAMIC SUPPORT. IT WAS REPORTED THAT THE PATIENT STILL HAD SOME BLEEDING FROM THE CHEST TUBES THAT STAFF WAS TRYING TO CONTROL. PACKED RED BLOOD CELLS AND FRESH FROZEN PLASMA WERE ADMINISTERED TO THE PATIENT. IT WAS REPORTED THAT AFTER 76.27 HOURS OF IMPELLA 5.0 SUPPORT THAT CARE WAS WITHDRAWN. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20792775 ↗
• MalfunctionNov 27, 2024Restricted Flow rate; Restricted Flow rate

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT THE PUMP HAD LOW FLOWS WHICH PROMPTED EXPLANT AND A PLANNED ESCALATION OF SUPPORT TO THE 5.5. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792611 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH RISK PERCUTANEOUS CORONARY INSERTION WAS IMPLANTED WITH AN IMPELLA 5.0 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, PLANS WERE MADE TO CONTINUE WEANING THE IMPELLA AS THE PHYSICIANS FELT THE IMPELLA WAS CAUSING HEMOLYSIS. IT WAS ALSO NOTED THAT SYSTEMIC HEPARIN WAS PUT ON HOLD DUE TO POTENTIAL BLEED IN AXILLARY AREA ASSOCIATED WITH A JP DRAIN. THE PATIENT CONTINUED ON SUPPORT UNTIL THE DEVICE WAS SUCCESSFULLY WEANED.

  Patient problems: Hemolysis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20791034 ↗
• InjuryNov 26, 2024Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK/LOW CARDIAC OUTPUT SYNDROME WAS IMPLANTED WITH AN IMPELLA LD FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE DOPPLER PULSES IN BILATERAL LOWER EXTREMITIES. ALSO NOTED HIGH PURGE PRESSURE ALARM. ALARMS PERSISTED DESPITE TISSUE PLASMINOGEN ACTIVATOR (TPA) INFUSIONS VIA THE PURGE. THE PATIENT WAS SUCCESSFULLY WEANED FROM THE IMPELLA AND THE DEVICE EXPLANTED.

  Patient problems: Ischemia

  MAUDE report 20789722 ↗
• DeathNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED THAT THE PATIENT WAS BEING PLACED ON IMPELLA 5.0 FOR HEMODYNAMIC SUPPORT. IT WAS REPORTED THAT THE PATIENT HAD OOZING AT THE GROIN SITE. THE PATIENT RECEIVED ONE UNIT OF PACKED RED BLOOD CELLS AND FRESH FROZEN PLASMA. AFTER 62.28 HOURS OF IMPELLA 5.0 SUPPORT, THE FAMILY OPTED TO HAVE CARE WITHDRAWN WITH THE PATIENT EXPIRING, THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20789079 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA LD DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, PATIENT WAS BLEEDING. AS A RESULT, PATIENT WAS GIVEN BLOOD AND PLATELETS. PATIENT SURVIVED THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20761069 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK / LOW CARDIAC OUTPUT SYNDROME WAS ON AN IMPELLA LD FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED THAT DURING IMPELLA PLACEMENT, THE PATIENT EXPERIENCED BLEEDING COMPLICATIONS DUE TO AN EXTENSIVE PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S AORTA WAS REPATCHED, AND THE CHEST WAS OPEN POST OPERATION. IT WAS STATED THAT SEVEN UNITS OF RED BLOOD CELLS WERE PROVIDED, AND HEPARIN WAS REMOVED FROM THE PURGE IN AN EFFORT TO MANAGE THE COMPLICATION. WEANING WAS SUCCESSFUL, THE DEVICE WAS EXPLANTED, AND THE PROCEDURAL OUTCOME WAS THE PATIENT SURVIVED.

  Patient problems: Perforation of Vessels

  MAUDE report 20747939 ↗
• MalfunctionNov 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED A PATIENT WITH CARDIOMYOPATHY WAS ON AN IMPELLA LD FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE DEVICE EXHIBITED A PURGE LEAK FROM THE HUB, ALONG WITH BLOOD SLOWING LEAKING FROM BETWEEN THE CLEAR SIDE ARM AND RED IMPELLA PLUG. THE STAFF PERFORMED A PURGE RESERVOIR BYPASS WHICH RESOLVED THE PROBLEM. THE PATIENT CONTINUED ON SUPPORT, AND IT WAS REPORTED THAT THEY SURVIVED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747650 ↗
• DeathNov 21, 2024Positioning Failure; Positioning Failure

  THE USER FACILITY REPORTED A PATIENT WITH POST CARDIOTOMY CARDIOGENIC SHOCK / LOW CARDIAC OUTPUT SYNDROME WAS ON AN IMPELLA FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT, THE PATIENT EXPERIENCED HEMOLYSIS AND THE DEVICE WAS REPOSITIONED. ADDITIONAL INFORMATION NOTED THE PATIENT WAS MADE A DO NOT RESUSCITATE, CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED. THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

  Patient problems: Hemolysis

  MAUDE report 20747214 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT AN EPISODE OF BRADYCARDIA WAS NOTED DURING WEANING. THE PUMP WAS ADJUSTED BACK UP TO P6 WEANING WAS CONTINUED THE NEXT DAY. THE PATIENT OUTCOME WAS NOTED TO BE STABLE.

  Patient problems: Bradycardia

  MAUDE report 20744237 ↗
• InjuryNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION NEEDING AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT THE PATIENT EXPERIENCED A SUBARACHNOID HEMORRHAGE. ADDITIONALLY, IT WAS REPORTED THAT THE STAFF FAILED TO DISCONNECT THE YELLOW LUER. THE STAFF BELIEVED THAT THE PURGE CASSETTE WAS LEAKING, AND THIS ISSUE COULD BE RESOLVED BY CHANGING THE CASSETTE, HOWEVER THE RESOLUTION FOR THIS ISSUE IS UNKNOWN. THE PATIENT WAS BRIDGED TO A LEFT VENTRICULAR ASSIST DEVICE (LVAD).

  Patient problems: Stroke/CVA

  MAUDE report 20741691 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK NEEDING AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. DURING SUPPORT IT WAS REPORTED THAT THE PATIENT HAD INCREASED AMOUNTS OF BLEEDING. THE PATIENT WAS GIVEN 8 UNITS OF PACKED RED BLOOD CELLS ALONG WITH OTHER BLOOD PRODUCTS. HEPARIN WAS WITHHELD. IN ADDITION, THE PATIENT HAD NUMEROUS RUNS OF VENTRICULAR TACHYCARDIA REQUIRING DEFIBRILLATION AND MEDICATION. THE PATIENT REMAINED ON IMPELLA SUPPORT AND WAS SUCCESSFULLY WEANED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tachycardia

  MAUDE report 20741679 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NEEDING AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT DUE TO CARDIOMYOPATHY. WHILE ON SUPPORT IT WAS NOTED THAT THE PATIENT WAS GOING TO OPERATING ROOM FOR EXPLORATION FOR BLEEDING. PATIENT WAS RESTING ON SUPPORT, HOWEVER THE CHEST REMAINED OPEN. THE CHEST TUBE DRAINAGE WAS ACCEPTABLE AND PRBCS WERE TRANSFUSED FOR OVERALL SURGICAL BLEEDING. IN ADDITION, THE IMPELLA WAS WEANED. PUMP WAS EXPLANTED AT THE SAME TIME AS CLOSURE OF THE CHEST. IN ADDITION THE PATIENT EXPERIENCED A STROKE. THE PROCEDURE OUTCOME WAS THE PATIENT SURVIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 20741653 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINANT REPORTED A PATIENT NOTED AS HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION NEEDING AN IMPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT THERE WAS HEMOLYZING AND SURGICAL BLEEDING. A DIALYSIS LINE WAS PLACED AT THE BEDSIDE TO START CONTINUOUS RENAL REPLACEMENT THERAPY. HEPARIN WAS REMOVED DUE TO THE SURGICAL BLEED. THE PATIENT CONTINUED ON SUPPORT UNTIL THE DEVICE WAS SUCCESSFULLY WEANED.

  Patient problems: Hemolysis; Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 20741641 ↗