MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BO-VKMO 71000

Device Problem No Flow (2991)

Patient Problem Hypoxia (1918)

Event Date 02/26/2023

Event Type  Death  

Event Description

It was reported that in normal pressure values, gas exchange was absent.There was not any delta pressure increase however oxygenation loss was occurred.Patient died during treatment.Trackwise #: (b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when further information becomes available.

Manufacturer Narrative

It was reported that in normal pressure values, gas exchange was absent.There was not any delta pressure increase however oxygenation loss was occurred.The product was changed during treatment.Patient died in the intensive unit.The cause of death was described as multi-organ failure and it was stated that dead of patient was not caused by product.The sample was investigated at maquet cardiopulmonary gmbh laboratory on 2023-05-22.The reported failure could not be reproduced during the laboratory investigation.The production records of the affected oxygenator (lot 3000242476 / serial no.(b)(6)) were reviewed on 2023-05-30.Following tests are performed according to the bop (basic operation procedure) as a 100 % inspection: leak test after welding, pressure test heat exchanger, leak test water side , leak and flow test gas side, pressure test blood side , coating test.According to the final test results the oxygenator with the serial# (b)(6) passed the test as per specifications.Production related influences can be excluded.The production history record (dhr) of the affected bo-vkmo 71000 with lot# 3000266211 was reviewed on 2023-03-17.According to the dhr result, the product bo-vkmo 71000 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Getinge medical affairs conducted a medical review.The reported failure was described as: cardiopulmonary resuscitation was required to a patient that in septic shock with unstable hemodynamic.Lucas device was placed and medication was infused to patient.Extracorporeal circulation (cec) was started with implantation of peripheral arteriovenous cannulas (25fr and 22fr), and the act (activated clotting time) >600s.The circuit was later swapped after opening the sternum into central venous cannulation, bicaval cannulation 30-34fr.Massive loss of arterial and venous oxygenation was occurred at around 1.30 pm.Therefore, the patient was cooled down and the ¿module¿ (assumed oxygenator) was replaced.On the restart, blood gas values were reported to be normal.The patient was weaned from cec without the aid of mechanical aids.As a conclusion of medical review: the calculation of o2 transfer was performed with received information for an additional proof of the membrane functionality.The calculation of the gas transfer resulted in a transfer of oxygen of 260 ml/min/l, which is close to the o2 graph of the quadrox-i (ifu hmo 70000 / 71000).For 5 liters per minute blood flow the graph shows approx.320ml/min/l gas transfer.Therefore, the oxygenator is considered to be functional.Further, the received information from customer shows that at 14:28 the partial pressure of oxygen po2 was 509, while the saturation was 32.8%.In normal conditions, it is expected that at a po2 of 100 mmhg, haemoglobin will be 100% saturated with oxygen.Reasons of the low saturation could be linked to: the low hemoglobin content, that was present in the patient, may have resulted in a lower saturation, as only oxygen, bound to hemoglobin is effective for the tissue saturation.The blood hemoglobin concentration is determinant of oxygen delivery.In anemic patients, oxygen delivery decreases and oxygen extraction is increased.This leads to decreased hemoglobin saturation and a lower tissue oxygen saturation.The rate of tissue deoxygenation during ischemia is dependent on oxygen consumption and on the amount of oxygen available in the tissue.The customer described that the patient was in sepsis.Sepsis present in patient might have led to the low saturation and other parameters seen in the perfusion protocol.Septic shock occurs in a subset of patients with sepsis and comprises of an underlying circulatory and cellular/metabolic abnormality that is associated with increased mortality.Septic shock is defined by persisting hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm hg or higher and a serum lactate level greater than 2 mmol/l (18 mg/dl) despite adequate volume resuscitation.The blood gas data around the time of the event shows that the patient appeared to be in profound metabolic acidosis.Profound acidosis stimulates a rightward shift (bohr effect) in the oxygen-dissociation curve, triggering an increased release of hemoglobin-bound oxygen to the tissues and, therefore, increased po2 values.However, an increased release of o2 from hemoglobin at the level of the tissues may affect the ability of the oxygenator to preload unbound hemoglobin with sufficient oxygen.This condition may be exacerbated by a low hemoglobin concentration, increase in cardiac output (causing deceased transit time), and an elevated concentration of o2-depleted hemoglobin.A low fio2 (fraction of inspired oxygen) may contribute to the amount of oxygen transferred to the blood by the oxygenator, hence, reducing sao2 and pao2.However, customer does not provide the concentration of the fio2 value.The probable root cause of the reported failure has been found as patient-related influences.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint # (b)(4).

Manufacturer Narrative

It was reported that in normal pressure values, gas exchange was absent.There was not any delta pressure increase however oxygenation loss was occurred.The product was changed during treatment.Patient died in the intensive unit.The cause of death was described as multi-organ failure and it was stated that dead of patient was not caused by product.The sample was investigated at maquet cardiopulmonary gmbh laboratory on 2023-05-22.The reported failure could not be reproduced during the laboratory investigation.The production records of the affected oxygenator (lot: 3000242476 / serial no: (b)(6) were reviewed on 2023-05-30.Following tests are performed according to the bop (basic operation procedure) as a 100 % inspection: leak test after welding, pressure test heat exchanger, leak test water side, leak and flow test gas side , pressure test blood side, coating test.According to the final test results the oxygenator with the serial#: (b)(6) passed the test as per specifications.Production related influences can be excluded.The production history record (dhr) of the affected bo-vkmo 71000 with lot#: 3000266211 was reviewed on 2023-03-17.According to the dhr result, the product bo-vkmo 71000 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The medical review has been revised on 2023-10-19 to adapt the previous wording used: getinge medical affairs conducted a medical review.The reported failure was described as: cardiopulmonary resuscitation was required to a patient that in septic shock with unstable hemodynamic.Lucas device was placed and medication was infused to patient.Extracorporeal circulation (cec) was started with implantation of peripheral arteriovenous cannulas (25fr and 22fr), and the act (activated clotting time) >600s.The circuit was later swapped after opening the sternum into central venous cannulation, bicaval cannulation 30-34fr.Massive loss of arterial and venous oxygenation was occurred at around 1.30 pm.Therefore, the patient was cooled down and the ¿module¿ (assumed oxygenator) was replaced.On the restart, blood gas values were reported to be normal.The patient was weaned from cec and expired sometime afterwards.As a conclusion of medical review: the calculation of o2 transfer was performed with received information for an additional proof of the membrane functionality.The calculation of the gas transfer resulted in a transfer of oxygen of 260 ml/min/l, which is close to the o2 graph of the quadrox-i (ifu hmo 70000 / 71000).For 5 liters per minute blood flow the graph shows approx.320ml/min/l gas transfer.Therefore, the oxygenator is considered to be functional.Further, the received information from customer shows that at 14:28 the partial pressure of oxygen po2 was 509, while the saturation was 32.8%.In normal conditions, it is expected that at a po2 of 100 mmhg, haemoglobin will be 100% saturated with oxygen.Reasons of the low saturation could be linked to: the low hemoglobin content, that was present in the patient, may have resulted in a lower saturation, as only oxygen, bound to hemoglobin is effective for the tissue saturation.The blood hemoglobin concentration is determinant of oxygen delivery.In anemic patients, oxygen delivery decreases and oxygen extraction is increased.This leads to decreased hemoglobin saturation and a lower tissue oxygen saturation.The rate of tissue deoxygenation during ischemia is dependent on oxygen consumption and on the amount of oxygen available in the tissue.The customer described that the patient was in sepsis.Sepsis present in patient might have led to the low saturation and other parameters seen in the perfusion protocol.Septic shock occurs in a subset of patients with sepsis and comprises of an underlying circulatory and cellular/metabolic abnormality that is associated with increased mortality.Septic shock is defined by persisting hypotension requiring vasopressors to maintain a mean arterial pressure of 65 mm hg or higher and a serum lactate level greater than 2 mmol/l (18 mg/dl) despite adequate volume resuscitation.The blood gas data around the time of the event shows that the patient appeared to be in profound metabolic acidosis.Profound acidosis stimulates a rightward shift (bohr effect) in the oxygen-dissociation curve, triggering an increased release of hemoglobin-bound oxygen to the tissues and, therefore, increased po2 values.However, an increased release of o2 from hemoglobin at the level of the tissues may affect the ability of the oxygenator to preload unbound hemoglobin with sufficient oxygen.This condition may be exacerbated by a low hemoglobin concentration, increase in cardiac output (causing deceased transit time), and an elevated concentration of o2-depleted hemoglobin.A low fio2 (fraction of inspired oxygen) may contribute to the amount of oxygen transferred to the blood by the oxygenator, hence, reducing sao2 and pao2.However, customer does not provide the concentration of the fio2 value.The patient was weaned from support (as disclosed by the customer), however expired sometime after weaning from extracorporeal support.Therefore, drawing a correlation between the product and the outcome of the patient is challenging as the customer stated that the product did not contribute to the expiration the patient.The probable root cause of the reported failure has been found as patient-related influences.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

It was reported that in normal pressure values, gas exchange was absent.There was not any delta pressure increase however oxygenation loss was occurred.Patient died during treatment.Complaint#: (b)(4).

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16521215
• MDR Text Key: 311050440
• Report Number: 3008355164-2023-00010
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BO-VKMO 71000
• Device Catalogue Number: 701067951
• Device Lot Number: 3000266211
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2023
• Distributor Facility Aware Date: 10/19/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2023
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 47 YR
• Patient Sex: Prefer Not To Disclose