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

Model Number BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.

Device Problem Pressure Problem (3012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The sales and service unit informed that the oxygenator was scrapped by the customer.

Event Description

The event occurred in (b)(6).It was reported from the customer that they had a quadrox id clot off on the initiation of ecmo.An emergent aortic dissection case was converted to av ecmo following a long cpb run with dhca.Inflow was through a central venous 2-stage and return was through a right axillary cannula, both cannula were used throughout the bypass run.Initial flows were 4-5 lpm with typical ecmo flow drops related to volume loss from ongoing bleeding but were easily remedied by temporarily decreasing flows and administering volume.Bleeding was treated with quick transfusions of ffp, platelets, fibrinogen and octaplex.Shed blood was collected in the cell saver, processed and re-administered.After about 25 minutes, there was a sudden drop in ecmo flow to 0.5 lpm.Upon inspection, the circuit appeared intact; no clot was noted in the pump head or on the inflow surface of the oxygenator.Troubleshooting was typical, dropping rpm¿s to allow greater right-sided filling, administration of additional volume, echo inspection of venous cannula placement and visual inspection of our circuit.After several minutes of trouble shooting, the surgeon was agreeable to replacing the venous cannula, following this ecmo flows remained 0.5 lpm.We proceeded to checking pre & post membrane pressures, which were approx.400 mmhg on the inflow side and approx.10 mmhg on the outflow side.The oxygenator was replaced and were able to reestablish flows of 4-5 lpm.Upon inspection of the oxygenator, no clots were visible on the inflow or outflow surface.Unfortunately, the oxygenator was accidentally thrown away.Additional information: the customer stated that the clot was unidentified within the circuit nor the oxygenator, but attributed to the drop in pressure to a "potential clot".There was no patient harm reported in the ecmo processes.The injury occurred in the surgery prior to ecmo initiation.The aortic dissection happened in the surgery and as a result of this dissection the patient needed ecmo.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in canada.It was reported from the customer that they had a quadrox id clot off on the initiation of ecmo.An emergent aortic dissection case was converted to av ecmo following a long cpb run with dhca.Inflow was through a central venous 2-stage and return was through a right axillary cannula, both cannula were used throughout the bypass run.Initial flows were 4-5 lpm with typical ecmo flow drops related to volume loss from ongoing bleeding but were easily remedied by temporarily decreasing flows and administering volume.Bleeding was treated with quick transfusions of ffp, platelets, fibrinogen and octaplex.Shed blood was collected in the cell saver, processed and re-administered.After about 25 minutes, there was a sudden drop in ecmo flow to 0.5 lpm.Upon inspection, the circuit appeared intact; no clot was noted in the pump head or on the inflow surface of the oxygenator.Troubleshooting was typical, dropping rpm¿s to allow greater right-sided filling, administration of additional volume, echo inspection of venous cannula placement and visual inspection of our circuit.After several minutes of trouble shooting, the surgeon was agreeable to replacing the venous cannula, following this ecmo flows remained 0.5 lpm.We proceeded to checking pre & post membrane pressures, which were approx.400 mmhg on the inflow side and approx.10 mmhg on the outflow side.The oxygenator was replaced and were able to reestablish flows of 4-5 lpm.Upon inspection of the oxygenator, no clots were visible on the inflow or outflow surface.Unfortunately, the oxygenator was accidentally thrown away.Additional information: the customer stated that the clot was unidentified within the circuit nor the oxygenator, but attributed to the drop in pressure to a "potential clot".There was no patient harm reported in the ecmo processes.The injury occurred in the surgery prior to ecmo initiation.The aortic dissection happened in the surgery and as a result of this dissection the patient needed ecmo.The affected oxygenator hmod 70000 with lot# 70140069 was disposed by the customer, thus no laboratory investigation was possible.For further investigation patient data was collected and a medical assessment was performed by getinge medical affairs specialist on 2021-03-09: the customer mentioned that ffp platelets, fibrinogen, and octaplex were administered to the patient during support.Octaplex is a pooled plasma coagulation factor concentrate which contains coagulation factors ii (220 ¿ 760iu), vii (180 ¿ 480iu), ix (500iu) and x (360 ¿ 600iu) in each vial.It also contains protein c, protein s, albumin, heparin and sodium citrate.Given that ffp, platelets, fibrinogen, and octaplex all accelerate the clotting process, the administration of these components during support may have stimulated the clotting cascade and resulted in clotting even though it was not identified by the user.Furthermore, the addition of these elements/components in rapid succession may have exacerbated clotting in the support circuit.The quadrox-id instructions for use | 1.6 | g-306 | 05 states the following with respect to maintenance of proper anti-coagulation balance during use of the product: no anti-coagulation or insufficient anti-coagulation causes occlusion of the extracorporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.¿ weigh up the benefits of extracorporeal circulation against the risk of systemic anticoagulation.¿ use anticoagulants; e.G., heparin or argatroban.¿ check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).Ensure that the act value does not fall below the value which is appropriate for the application.¿ check the coagulation status of the patient's blood regularly.The protocol for coagulation management is the responsibility of the user in charge.¿ this device can be used for ecmo and hlm procedures.The anti-coagulation management for this device must correspond to the intended conditions for the respective application.Additionally, a cell saver device removes heparin and clotting factors during the washing process.As the processed blood is administered back to the patient, the delivered product would contain no heparin and, therefore, may have contributed to clotting in the oxygenator.The overall effect, however, depends on how much blood was/is processed through the cell saver and, subsequently, re-administered to the patient.Based on this the reported issue "flow dropped" could be confirmed but no product related malfunction.The most probable root cause could be determined as a coagulation of the membrane caused by insufficient anti-coagulation.The coagulation can lead to a blockage and thus an extension of the diffusion path lowering the oxygenating performance and decreasing the flow.The occurrence rate was calculated for the reported issue 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 id: (b)(4).

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11326890
• MDR Text Key: 233786153
• Report Number: 8010762-2021-00116
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2022
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Device Lot Number: 70140069
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1