EXCOR® P30P-001x01Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 04260090040126), received between Aug 26, 2015 and May 13, 2025 — classified as 31 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Output Problem” (46 reports).

2 FDA recall records name this device's identifier, 1 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 16, 2026.

Recalls naming this device

1. Apr 24, 2026Open, Classified

   Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

   Z-2320-2026 · Root cause: Error in labeling · Recall details · FDA record ↗

2. May 18, 2018Terminated

   There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.

   Z-1618-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON 2025-04-29, THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT BLOOD WAS OBSERVED BETWEEN THE BLOOD MEMBRANE LAYERS OF THE EXCOR BLOOD PUMP PU VALVES; 30 ML, IN/OUT; Ø 9 MM. THE SITE REPORTED THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THIS TIME AND THE BLOOD PUMP MAINTAINED FULL FILLING AND EJECTION AS INTENDED. THE SITE ALSO REPORTED THAT A VISUAL IRREGULARITY OF THE MEMBRANE WAS APPARENT WHEN ASSESSING THE PUMP FROM THE AIR CHAMBER SIDE. UPON EVALUATION OF THE VIDEOS PROVIDED BY THE SITE, BHI CA RECOMMENDED AN IMMEDIATE PUMP CHANGE. THE BLOOD PUMP WAS CHANGED SUCCESSFULLY WITHOUT ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013911 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE PATIENT SUPPORTED WITH AN EXCOR BLOOD PUMP IN BI-VAD CONFIGURATION DEVELOPED HEMOLYSIS. THE PATIENT'S LDH VALUE INCREASED TO 2511U/L, WHEREAS THE LDH VALUE INDICATED 937 U/L BEFORE IMPLANTATION. THE PATIENT WAS INITIALLY SUPPORTED WITH EXCOR ACTIVE DRIVER THEN TRANSITIONED TO AN IKUS DRIVER DUE TO AN INCREASE IN HEMOLYSIS. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS PU VALVES; 30 ML IN/OUT; Ø 9 MM; RVAD SN (B)(6) AND LVAD, SN (B)(6) PERFORMED AS INTENDED FOR CLINICAL CONDITION WITH FULL FILL AND EJECTION. THERE WERE NO DEPOSITS NOTED IN THE EXCOR BLOOD PUMPS. ON (B)(6) 2024 BHI CA WAS INFORMED THAT THE PATIENT WAS ESCALATED TO CENTRIMAG DUE TO CONTINUED HEMOLYSIS.

  Patient problems: Hemolysis

  MAUDE report 20318171 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE PATIENT SUPPORTED WITH AN EXCOR BLOOD PUMP IN BI-VAD CONFIGURATION DEVELOPED HEMOLYSIS. THE PATIENT'S LDH VALUE INCREASED TO 2511U/L, WHEREAS THE LDH VALUE INDICATED 937 U/L BEFORE IMPLANTATION. THE PATIENT WAS INITIALLY SUPPORTED WITH EXCOR ACTIVE DRIVER THEN TRANSITIONED TO AN IKUS DRIVER DUE TO AN INCREASE IN HEMOLYSIS. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS PU VALVES; 30 ML IN/OUT; Ø 9 MM; LVAD, SN (B)(6) AND RVAD SN (B)(6) PERFORMED AS INTENDED FOR CLINICAL CONDITION WITH FULL FILL AND EJECTION. THERE WERE NO DEPOSITS NOTED IN THE EXCOR BLOOD PUMPS. ON 2024-09-12 BHI CA WAS INFORMED THAT THE PATIENT WAS ESCALATED TO CENTRIMAG DUE TO CONTINUED HEMOLYSIS.

  Patient problems: Hemolysis

  MAUDE report 20318115 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE PATIENT SUPPORTED WITH AN EXCOR BLOOD PUMP IN BI-VAD CONFIGURATION DEVELOPED HEMOLYSIS. THE PATIENT'S LDH VALUE INCREASED TO 2511U/L, WHEREAS THE LDH VALUE INDICATED 937 U/L BEFORE IMPLANTATION. THE PATIENT WAS INITIALLY SUPPORTED WITH EXCOR ACTIVE DRIVER THEN TRANSITIONED TO AN IKUS DRIVER DUE TO AN INCREASE IN HEMOLYSIS. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS PU VALVES; 30 ML IN/OUT; Ø 9 MM; RVAD SN (B)(6) AND LVAD, SN (B)(6) PERFORMED AS INTENDED FOR CLINICAL CONDITION WITH FULL FILL AND EJECTION. THERE WERE NO DEPOSITS NOTED IN THE EXCOR BLOOD PUMPS. ON (B)(6) 2024 BHI CA WAS INFORMED THAT THE PATIENT WAS ESCALATED TO CENTRIMAG DUE TO CONTINUED HEMOLYSIS.

  Patient problems: Hemolysis

  MAUDE report 20317490 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE PATIENT SUPPORTED WITH AN EXCOR BLOOD PUMP IN BI-VAD CONFIGURATION DEVELOPED HEMOLYSIS. THE PATIENT'S LDH VALUE INCREASED TO 2511U/L, WHEREAS THE LDH VALUE INDICATED 937 U/L BEFORE IMPLANTATION. THE PATIENT WAS INITIALLY SUPPORTED WITH EXCOR ACTIVE DRIVER THEN TRANSITIONED TO AN IKUS DRIVER DUE TO AN INCREASE IN HEMOLYSIS. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMPS PU VALVES; 30 ML IN/OUT; Ø 9 MM; LVAD, SN (B)(6) AND RVAD SN (B)(6) PERFORMED AS INTENDED FOR CLINICAL CONDITION WITH FULL FILL AND EJECTION. THERE WERE NO DEPOSITS NOTED IN THE EXCOR BLOOD PUMPS. ON 2024-09-12 2024 BHI CA WAS INFORMED THAT THE PATIENT WAS ESCALATED TO CENTRIMAG DUE TO CONTINUED HEMOLYSIS.

  Patient problems: Hemolysis

  MAUDE report 20317207 ↗
• InjuryApr 15, 2024Output Problem; Output Problem

  THE SITE CONTACTED BERLIN HEART INC. TO REPORT THAT THE PATIENT EXPERIENCED ACUTE NEUROLOGICAL CHANGES AND SUBSEQUENTLY SUFFERED A CARDIAC ARREST. DURING CPR, ONE OF THE NURSES NOTED AIR BUBBLES RESEMBLING FOAM IN THE PUMP. ON 3/21/24, THE SITE REPORTED THAT DURING THE EVENT, THE LEFT VENTRICLE HAD EMPTIED SIGNIFICANTLY AND THE PUMP WAS NOT FILLING, A DECISION WAS MADE TO DECREASE THE RATE ON THE IKUS DRIVER AND SUBSTITUTE VOLUME. THE AIR IN THE PUMP WAS NO LONGER VISIBLE, AND THE PUMP BEGAN FILLING COMPLETELY. THE SITE ALSO REPORTED THE PRESENCE OF AIR IN THE RIGHT HEART. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LA LINE PLACED AT THE TIME OF THE IMPLANT. AFTER FURTHER DISCUSSION WITH THE SITE, THE SOURCE OF THE AIR COULD NOT BE DETERMINED. THE SITE ALSO REPORTED THAT THERE WAS NOTHING UNUSUAL WITH THE CANNULAS OR PUMP/MEMBRANE THAT COULD POTENTIALLY INTRODUCE AIR TO THE PATIENT.

  Patient problems: Embolism/Embolus

  MAUDE report 19109994 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE NOTIFIED BERLIN HEART INC. CLINICAL AFFAIRS THAT A PUMP CHANGE HAD OCCURRED ON A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM DUE TO AN AUDIBLE "CRUNCHING" NOISE. ADDITIONAL INFORMATION PROVIDED BY THE SITE, ON 03-01-2024, REPORTED THAT THE PATIENT WAS EXHIBITED LDH LAB VALUES CONSISTENT WITH HEMOLYSIS. THE PATIENT'S LDH LEVEL INCREASED FROM 508 ON 2024-02-13 TO 1200 ON 2024-02-25. ACCORDING TO THE SITE, THE BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION THROUGHOUT.

  Patient problems: Hemolysis

  MAUDE report 18881560 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE NOTIFIED BERLIN HEART INC. CLINICAL AFFAIRS THAT A PUMP CHANGE HAD OCCURRED ON A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM DUE TO AN AUDIBLE "CRUNCHING" NOISE. ADDITIONAL INFORMATION PROVIDED BY THE SITE, ON (B)(6) 2024, REPORTED THAT THE PATIENT WAS EXHIBITED LDH LAB VALUES CONSISTENT WITH HEMOLYSIS. THE PATIENT'S LDH LEVEL INCREASED FROM 508 ON (B)(6) 2024 TO 1200 ON (B)(6) 2024 . ACCORDING TO THE SITE, THE BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION THROUGHOUT.

  Patient problems: Hemolysis

  MAUDE report 18880014 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART WAS INFORMED BY THE SITE ON (B)(6) 2024 THAT A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM HAD DEVELOPED HEMOLYSIS. THE PATIENT'S LDH VALUE INCREASED TO 1092, WITH AN INCREASED TOTAL BILIRUBIN OF 2.4MD/DL. THE UPPER LIMIT OF NORMAL FOR LDH AT THIS HOSPITAL IS 409. THE SITE IS CONTINUING TO MONITOR HEMOLYSIS VALUES. THE PUMP FUNCTIONED AS INTENDED WITH COMPLETE FILL AND EJECTION AND REMAINED ON THE PATIENT.

  Patient problems: Hemolysis

  MAUDE report 18842074 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART WAS INFORMED BY THE SITE ON (B)(6) 2024 THAT A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM HAD DEVELOPED HEMOLYSIS. THE PATIENT'S LDH VALUE INCREASED TO 1092, WITH AN INCREASED TOTAL BILIRUBIN OF 2.4MD/DL. THE UPPER LIMIT OF NORMAL FOR LDH AT THIS HOSPITAL IS 409. THE SITE IS CONTINUING TO MONITOR HEMOLYSIS VALUES. THE PUMP FUNCTIONED AS INTENDED WITH COMPLETE FILL AND EJECTION AND REMAINED ON THE PATIENT.

  Patient problems: Hemolysis

  MAUDE report 18842067 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE NOTIFIED BERLIN HEART INC. CLINICAL AFFAIRS THAT ON 02-22-2024 A PUMP CHANGE WAS PERFORMED DUE TO HEMOLYIS AND SQUEAKING AT THE VALVES, LOUDER AT THE OUTFLOW THAN THE INFLOW VALVE. THE PATIENT'S LDH LEVEL INCREASED FROM 1853 ON 02-20-2024 TO 2494 ON 02-22-2024. ACCORDING TO THE SITE, THE PUMP MAINTAINED FULL FILL AND EJECTION AND FUNCTIONED AS INTENDED.

  Patient problems: Hemolysis

  MAUDE report 18842062 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE NOTIFIED BERLIN HEART INC. CLINICAL AFFAIRS THAT ON (B)(6) 2024, A PUMP CHANGE WAS PERFORMED DUE TO HEMOLYIS AND SQUEAKING AT THE VALVES, LOUDER AT THE OUTFLOW THAN THE INFLOW VALVE. THE PATIENT'S LDH LEVEL INCREASED FROM 1853 ON (B)(6) 2024 TO 2494 ON (B)(6) 2024. ACCORDING TO THE SITE, THE PUMP MAINTAINED FULL FILL AND EJECTION AND FUNCTIONED AS INTENDED.

  Patient problems: Hemolysis

  MAUDE report 18842044 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BHI CLINICAL AFFAIRS ON 1/28/2023 TO REPORT A "SQUEAKING PUMP". ACCORDING TO THE SITE, THE SQUEAKING SOUND WAS INTERMITTENT, AND RESOLVED WHEN LIGHT PRESSURE WAS APPLIED TO THE OUTFLOW VALVE. THE PUMP CONTINUES TO FUNCTION AS EXPECTED, WITH COMPLETE FILLING AND EJECTION. A VIDEO OF THE PUMP WAS PROVIDED BY THE SITE, WHICH DEMONSTRATED THE COMPLAINT. NO CURRENT HEMOLYSIS LAB VALUES WERE AVAILABLE BUT WERE REQUESTED BY BHI. SINCE THE SITE DID NOT REPORT ANY ADVERSE IMPACT TO PATIENT ASSOCIATED PURPORTED ABNORMALITY AT THE TIME OF THE EVENT, IT WAS DETERMINED AS NOT REPORTABLE. THE SITE CONTACTED BHI CLINICAL AFFAIRS AGAIN ON 4/4/2023 TO REPORT AN INCREASE IN THE "SQUEAKING NOISE" OF THE PUMP. THEY ALSO STATED IT SOUNDED LIKE THE PUMP HAD AN "INCREASE IN FRICTION." PHOTOS AND VIDEOS OF THE PUMP WERE OBTAINED. THE SITE ALSO REPORTED THAT THE PATIENT HAD AN INCREASED LDH (BUT DID NOT REPORT AN EXACT VALUE), AND AFTER REVIEWING THE PHOTOS & VIDEOS PROVIDED BY THE SITE, BERLIN HEART RECOMMENDED PUMP CHANGE. THE SITE CHANGED THE PUMP ON (B)(6)2023. HOWEVER, SITE DID NOT REPORT LDH VALUES UNTIL (B)(6)2023. AFTER REVIEWING THESE VALUES, IT WAS DETERMINED THAT THIS EVENT SH

  Patient problems: Hemolysis

  MAUDE report 16890037 ↗
• InjuryMay 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BHI CLINICAL AFFAIRS ON (B)(6) 2023 TO REPORT A "SQUEAKING PUMP". ACCORDING TO THE SITE, THE SQUEAKING SOUND WAS INTERMITTENT, AND RESOLVED WHEN LIGHT PRESSURE WAS APPLIED TO THE OUTFLOW VALVE. THE PUMP CONTINUES TO FUNCTION AS EXPECTED, WITH COMPLETE FILLING AND EJECTION. A VIDEO OF THE PUMP WAS PROVIDED BY THE SITE, WHICH DEMONSTRATED THE COMPLAINT. NO CURRENT HEMOLYSIS LAB VALUES WERE AVAILABLE BUT WERE REQUESTED BY BHI. SINCE THE SITE DID NOT REPORT ANY ADVERSE IMPACT TO PATIENT ASSOCIATED PURPORTED ABNORMALITY AT THE TIME OF THE EVENT, IT WAS DETERMINED AS NOT REPORTABLE. THE SITE CONTACTED BHI CLINICAL AFFAIRS AGAIN ON (B)(6) 2023, TO REPORT AN INCREASE IN THE "SQUEAKING NOISE" OF THE PUMP. THEY ALSO STATED IT SOUNDED LIKE THE PUMP HAD AN "INCREASE IN FRICTION." PHOTOS AND VIDEOS OF THE PUMP WERE OBTAINED. THE SITE ALSO REPORTED THAT THE PATIENT HAD AN INCREASED LDH (BUT DID NOT REPORT AN EXACT VALUE), AND AFTER REVIEWING THE PHOTOS & VIDEOS PROVIDED BY THE SITE, BERLIN HEART RECOMMENDED PUMP CHANGE. THE SITE CHANGED THE PUMP ON (B)(6) 2023. HOWEVER, SITE DID NOT REPORT LDH VALUES UNTIL (B)(6) 2023. AFTER REVIEWING THESE VALUES, IT WAS DETERMINED THAT THIS

  Patient problems: Hemolysis

  MAUDE report 16883684 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART WAS INFORMED BY THE CLINIC THAT A PATIENT THAT WAS IMPLANTED ON (B)(6) 2023 IN THE LVAD CONFIGURATION HAD AN ADVERSE EVENT ON (B)(6) 2023. THE CLINIC REPORTED THAT THE PATIENT SUFFERED FROM A CVA, BUT IS RECOVERING NOW. THERE WAS A CLOT THAT IMPACTED ON AN IMPORTANT CEREBRAL ARTERY. THE CLOT IS STILL THERE. FROM THE VISIT ON (B)(6) 2023 THE PATIENT WAS REGAINING MOBILITY IN HIS LEFT ARM, ALTHOUGH HE STILL HAD DIFFICULTY SPEAKING, COULD SIT UP ON HIS OWN AND DRAW. THE DOCTORS DECIDED NOT TO PERFORM ANY THROMBECTOMY THIS TIME BUT, IN CASE IT HAPPENS AGAIN, THEY WANT TO PROCEED IMMEDIATELY WITHOUT FURTHER DISCUSSION. ON (B)(6) 2023 THROMBUS DEVELOPED IN ATRIAL CANNULA, SO THE DEPOSIT WAS REMOVED AND CONTINUED SUPPORT WITHOUT FURTHER EVENTS OR FINDINGS. THE PATIENT IS STABLE ON SYSTEM AND RECOVERING FROM ADVERSE EVENT.

  Patient problems: Ischemia Stroke

  MAUDE report 16717134 ↗
• MalfunctionDec 29, 2022Output Problem; Output Problem

  BERLIN HEART WAS INFORMED BY OUR ITALIAN DISTRIBUTOR TO REPORT THAT THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED WITH EXCOR VAD SYSTEM WAS NOT COMPLETELY EMPTYING. FURTHER, THE CLINIC REPORTED THAT THE MEMBRANE APPEARED TO BE TOUCHING THE BLOOD PUMP HOUSING. THE CLINIC PROVIDED BERLIN HEART WITH VIDEO MATERIAL OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. HOWEVER, THE CLINIC EXCHANGED THE AFFECTED BLOOD PUMP WITHOUT PRIOR CONSULTATION OF BERLIN HEART. THE PATIENT SUFFERED NO LASTING EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068950 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART WAS NOTIFIED ON (B)(6) 2022, THAT ON (B)(6) 2022, THE PATIENT EXHIBITED LEFT-SIDED WEAKNESS, AND ASYMMETRY OF THE FACE. A HEAD CT AND CTA OF THE HEAD AND NECK WERE OBTAINED, SHOWING A RMCA EMBOLIC STROKE. THE PATIENT UNDERWENT AT A SUCCESSFUL THROMBECTOMY AND IS RECOVERING IN THE ICU. THE SITE REPORTED THAT THE PATIENT IS MOVING ALL EXTREMITIES AND HAS HAD A FULL NEUROLOGICAL RECOVERY. THE SITE ALSO REPORTED THAT AT THE TIME OF THE EVENT, THROMBIN WAS NOTED IN THE METAL CONNECTOR ON THE OUTFLOW 6-9 CONNECTING SET. TWO PUMP "CLEAN-OUTS" WERE PERFORMED TO REMOVE THE FIBRIN. THE ECXOR BLOOD PUMP CONTINUED TO FUNCTION AS EXPECTED, WITH COMPLETE FILLING AND EMPTYING

  Patient problems: Ischemia Stroke

  MAUDE report 15676818 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART WAS NOTIFIED ON (B)(6) 2022, THAT ON (B)(6) 2022, THE PATIENT EXHIBITED LEFT-SIDED WEAKNESS, AND ASYMMETRY OF THE FACE. A HEAD CT AND CTA OF THE HEAD AND NECK WERE OBTAINED, SHOWING A RMCA EMBOLIC STROKE. THE PATIENT UNDERWENT AT A SUCCESSFUL THROMBECTOMY AND IS RECOVERING IN THE ICU. THE SITE REPORTED THAT THE PATIENT IS MOVING ALL EXTREMITIES AND HAS HAD A FULL NEUROLOGICAL RECOVERY. THE SITE ALSO REPORTED THAT AT THE TIME OF THE EVENT, THROMBIN WAS NOTED IN THE METAL CONNECTOR ON THE OUTFLOW 6-9 CONNECTING SET. TWO PUMP "CLEAN-OUTS" WERE PERFORMED TO REMOVE THE FIBRIN. THE ECXOR BLOOD PUMP CONTINUED TO FUNCTION AS EXPECTED, WITH COMPLETE FILLING AND EMPTYING

  Patient problems: Ischemia Stroke

  MAUDE report 15676813 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SITE CONTACTED BERLIN HEART CA ON 9.15.2022 TO REPORT THAT THE PATIENT HAD ELEVATED LDH LEVELS, AND THE PUMP WAS EXCHANGED DUE TO CONCERNS FOR HEMOLYSIS. THE FOLLOWING LAB VALUES WERE REPORTED: (B)(6): PLASMA FREE HEMOGLOBIN - 235. (B)(6): LDH - 1383. (B)(6) LDH - 3900. NORMAL VALUES FOR THE SITE LDH 1383. PUMP MAINTAINED COMPLETED FILL AND EJECTION. SITE REPORTED THERE WERE NEITHER ACOUSTIC NOR VISUAL ABNORMALITIES ASSOCIATED WITH THE BLOOD PUMP. IN ADDITION, THERE ARE NO DEPOSITS REPORTED.

  Patient problems: Hemolysis

  MAUDE report 15498587 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SITE CONTACTED BERLIN HEART CA ON (B)(6) 2022 TO REPORT THAT THE PATIENT HAD ELEVATED LDH LEVELS, AND THE PUMP WAS EXCHANGED DUE TO CONCERNS FOR HEMOLYSIS. THE FOLLOWING LAB VALUES WERE REPORTED: (B)(6): PLASMA FREE HEMOGLOBIN - 235. (B)(6): LDH - 1383. (B)(6): LDH - 3900. NORMAL VALUES FOR THE SITE LDH -1383. PUMP MAINTAINED COMPLETED FILL AND EJECTION. SITE REPORTED THERE WERE NEITHER ACOUSTIC NOR VISUAL ABNORMALITIES ASSOCIATED WITH THE BLOOD PUMP. IN ADDITION, THERE ARE NO DEPOSITS REPORTED.

  Patient problems: Hemolysis

  MAUDE report 15498585 ↗
• MalfunctionSep 28, 2022Output Problem; Output Problem

  THE CLINIC CONTACTED BERLIN HEART TO REPORT THAT THEY HAD OBSERVED INCOMPLETE EMPTYING CONSISTENTLY FOR THE LAST 3 DAYS PRIOR TO REPORTING. AN OBSTRUCTION OF THE OUTFLOW CANNULA WAS RULED OUT BY A CT-SCAN OF THE CHEST. THE SYSTOLE VALUE WAS INCREASED TO 200 ON THE DRIVING UNIT WITH VERY LITTLE EFFECT. THE PATIENT WAS REPORTED TO REMAIN STABLE AND WELL SUPPORTED AT THE TIME OF THE REPORT. THE SITE THEN DECIDED TO EXCHANGE THE BLOOD PUMP DUE TO CONCERN FOR INABILITY TO FULLY EJECT. AFTER THE PUMP EXCHANGE ON (B)(6) 2022, FULL EMPTYING WAS OBSERVED WITH THE SYSTOLE VALUE RETURNED TO 180.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15497593 ↗
• MalfunctionFeb 25, 2022Material Discolored; Material Discolored

  BERLIN HEART WAS INFORMED BY THE DISTRIBUTOR ON 2021-10-15 ABOUT AN OPTICAL ANOMALY AT THE PUMP HOUSING OF THE EXCOR BLOOD PUMP OF A PATIENT IMPLANTED ON (B)(6) 2021 IN LVAD CONFIGURATION. PATIENT WAS ORIGINALLY PLACED ON EXCOR SYSTEM ON (B)(6) 2018. THE SITE REPORTED A GREEN LINE AND GREEN STAIN THAT SUDDENLY APPEARED ON THE SURFACE OF THE PUMP HOUSING. THE PUMP WAS FULLY FILLING AND EJECTING. AFTER CONSULTING BERLIN HEART CLINICAL AFFAIRS NO PUMP EXCHANGE WAS RECOMMENDED, SINCE THERE WAS NO NEGATIVE IMPACT ON THE PUMP FUNCTION AND THE PATIENT WAS DOING WELL. AT THAT DATE (2021-10-15) EVENT WAS DETERMINED AS NOT REPORTABLE. ON (B)(6) 2021 THE PATIENT HAD AN UNTOWARD EVENT WITH THE EXCOR CANNULA (SEE MDR 3004582654-2022-00006) . AFTER THE EVENT WITH THE CANNULA, THE CANNULA PARTS STILL CONNECTED TO THE EXCOR BLOOD PUMP WERE SENT BACK FOR ANALYSIS TO BERLIN HEART. DURING ANALYSIS OF THE CANNULA PARTS, STILL CONNECTED TO THE EXCOR BLOOD PUMP, BY CT SCAN, THE MEMBRANE DEFECT OF THE EXCOR BLOOD PUMP WAS NOTED ALSO. THEREFORE THE COMPLAINT INVESTIGATION (B)(4) WAS REOPENED AND DECISION FOR REPORTABILITY WAS MADE. (2022-02-21)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604514 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART, INC ON (B)(6) 2022 TO REPORT THAT A PATIENT SUPPORTED IN THE LVAD CONFIGURATION HAD DEVELOPED HEMOLYSIS AND WAS PLANNING A PUMP CHANGE. THE LDH LEVELS WERE AS FOLLOWS: BASELINE 853 ((B)(6) 2021); 1362 ((B)(6) 2021); 1263 ((B)(6) 2021); 1253 ((B)(6) 2021); 2056 ((B)(6) 2021); 1429 ((B)(6) 2021); 2365 ((B)(6) 2022), 4183 ((B)(6) 2022). THE HIGH END OF LDH NORMAL FOR THE SITE IS 334 FOR THIS PATIENT'S AGE. OF NOTE: THIS PATIENT'S BASELINE HAS ALWAYS BEEN ELEVATED DUE TO LIVER FAILURE SECONDARY TO A FAILING FONTAN PHYSIOLOGY. THE SITE ALSO REPORTED THAT THERE WAS A SOFT "CHIRP" THAT WAS AUDIBLE AT THE OUTFLOW VALVE SINCE (B)(6) 2021 AND THAT GOES AWAY WITH SLIGHT PRESSURE OVER THE PU VALVE. HOWEVER, THE SOUND RETURNS WHEN THE PRESSURE IS RELEASED. THIS CHIRP HAS BEEN UNCHANGED SINCE (B)(6) 2021. THE PUMP HAS BEEN FILLING AND EJECTING COMPLETELY, AND NO DIMPLES OR GRAPHITE DUST HAVE BEEN NOTED.

  Patient problems: Hemolysis

  MAUDE report 13446386 ↗
• MalfunctionFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE CONTACTED BERLIN HEART, INC ON (B)(6) 2022 TO REPORT THAT A PATIENT SUPPORTED IN THE LVAD CONFIGURATION HAD DEVELOPED HEMOLYSIS AND WAS PLANNING A PUMP CHANGE. THE LDH LEVELS WERE AS FOLLOWS: BASELINE 853 ((B)(6) 2021); 1362 ((B)(6) 2021); 1263 ((B)(6) 2021); 1253 ((B)(6) 2021); 2056 ((B)(6) 2021); 1429 ((B)(6) 2021); 2365 ((B)(6) 2022), 4183 ((B)(6) 2022). THE HIGH END OF LDH NORMAL FOR THE SITE IS 334 FOR THIS PATIENT'S AGE. OF NOTE: THIS PATIENT'S BASELINE HAS ALWAYS BEEN ELEVATED DUE TO LIVER FAILURE SECONDARY TO A FAILING FONTAN PHYSIOLOGY. THE SITE ALSO REPORTED THAT THERE WAS A SOFT "CHIRP" THAT WAS AUDIBLE AT THE OUTFLOW VALVE SINCE (B)(6) 2021 AND THAT GOES AWAY WITH SLIGHT PRESSURE OVER THE PU VALVE. HOWEVER, THE SOUND RETURNS WHEN THE PRESSURE IS RELEASED. THIS CHIRP HAS BEEN UNCHANGED SINCE (B)(6) 2021. THE PUMP HAS BEEN FILLING AND EJECTING COMPLETELY, AND NO DIMPLES OR GRAPHITE DUST HAVE BEEN NOTED.

  Patient problems: Hemolysis

  MAUDE report 13446384 ↗
• MalfunctionNov 30, 2021Output Problem; Output Problem

  BERLIN HEART WAS CONTACTED BY THE CLINIC TO REPORT A SUSPECTED MEMBRANE DEFECT IN THE LEFT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION, DUE TO AN INCOMPLETE EJECTION OF THE AFFECTED BLOOD PUMP. BERLIN HEART RECOMMENDED A PUMP EXCHANGE. THE AFFECTED BLOOD PUMP WAS EXCHANGED IN THE CLINIC BY TRAINED PERSONNEL. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897823 ↗