MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH ADULT OXYGENATOR, PMP, ABBOTT-BRANDED, PRIESTLEY; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 100174772

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/24/2023

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient had a bilateral lung transplant with a planned cardiopulmonary bypass on venoarterial extracorporeal membrane oxygenation (va ecmo).The patient was originally on an existing ecmo circuit with a 28fr rij dual-lumen crescent cannula on venovenous extracorporeal membrane oxygenation (vv-ecmo).A clot was noted at the top of the oxygenator at the start of the case.The perfusionist ran a post-oxygenator gas to confirm it would still function well for the transplant.The post-oxygenator po2 was >488 so the oxygenator appeared functional.The patient's heparin drip had been discontinued prior to wheelback that morning.The patient's baseline activated clotting time (act) was 189.The surgeon requested at 1000 iu of heparin be given during central arterial cannulation.Shortly after, the ecmo circuit was briefly clamped and converted to va ecmo.About 10 minutes after reinitiating ecmo, the centrimag pump went down to zero liters per minute (lpm).A high priority alarm for low flow event was consistently going off.The rotations per minute (rpm) were decreased and then increased several times by the perfusionist to relieve a possible suction event, but the flow never recovered.The pump head appeared to be spinning with rpms, but the flow never exceed about 0.5 lpm and soon dropped down to zero again.No chugging was visually observed on the venous side.It was unclear if the existing rij crescent cannula was the issue, so an additional 5000 iu of heparin was given and a central venous cannula was placed, which removed the rij cannula from the equation.An attempt was made to reestablish flow, but no flow was noted.The perfusion team passed off lines for a fresh ecmo circuit and an emergent circuit changeout was performed.Full flow was established with the fresh circuit and fresh central va ecmo cannulas.The malfunctioning circuit was fully drained and examined shortly after discontinuation.Some clot was noted on the top near the purge line as was noticed at the start of the case, but no visible clots were noted in the inlet or outlet of the system.The patient's bilateral lung transplant was successful, and they were discontinued off of ecmo before leaving the or.The patient was now awake and alert in the icu.Centrimag pump mfr # 3003306248-2023-05051.

Manufacturer Narrative

Manufacturer's investigation conclusion: visual inspection of the returned oxygenator confirmed a section with clotted blood; however, the clotted blood within the device did not appear to have caused a flow issue.The reported flow issue was unable to be confirmed, and a specific root cause for the flow issue could not be conclusively determined through this evaluation.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time.The supplier of the oxygenator (eurosets) was notified of the event, and eurosets evaluated the reported information.The root cause of the event was unable to be identified.Eurosets noted that clots may indicate difficult patient coagulation management resulting in increased pressure drops and flow difficulties.The issue was unable to be correlated to the device.The centrimag adult ecmo kit (cmaek) oxygenator was returned to abbott.Visual inspection of the oxygenator revealed no obvious damage.A section with clotted red blood was noted between the fibers below the purge line.The oxygenator was rinsed with water, and a small amount of loosely coagulated blood (visually appeared to be less than 10 milliliters) was rinsed out of the oxygenator (which has a residual blood volume of less than 200 ml).The section with clotted red blood below the purge line did not appear to be significantly changed following rinsing of the oxygenator.The returned cmaek oxygenator and blood pump were connected in a mock loop with water.Water flow of approximately 3.1 lpm was able to be established with pump speed of 1800 revolutions per minute (rpm).The clotted blood present in the oxygenator did not appear to be related to the reported flow issue, and the customer reported that the oxygenator operated as expected despite the initial clot noticed at the top of the oxygenator.The centrimag pre-connected pack instructions for use (ifu) lists potential adverse events associated with the use of any extracorporeal circuit.The ifu warns that anticoagulation levels and monitoring should be determined by the physician based on risks and benefits to the patient.The ifu warns to frequently monitor the patient and circuit.Monitor the circuit carefully during use for any signs of occlusion from kinks, chattering, and clot formation.The ifu also warns that a backup pack must be available immediately near the primary pack during support.The production documentation for the centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek) oxygenator, serial # (b)(6), (eurosets part #us5591; lot #75598704) was reviewed by the supplier (eurosets), and it was confirmed that all tests from the production process were compliant with the technical specifications.The relevant sections of the device history records for the cmaek serial # (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag pre-connected pack instructions for use (ifu), rev.B, is currently available.The ifu lists potential adverse events associated with the use of any extracorporeal circuit, including therapeutic management hypo-anticoagulation and vascular access site thromboembolism.The ifu contains the following general warnings: -only trained personnel should use the pack.-a backup pack must be available immediately near the primary pack during support.-anticoagulation levels and monitoring should be determined by the physician based on risks and benefits to the patient.-frequently monitor the patient and circuit.Monitor the circuit carefully during use for any signs of occlusion from kinks, chattering, and clot formation.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: ADULT OXYGENATOR, PMP, ABBOTT-BRANDED, PRIESTLEY
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 17542606
• MDR Text Key: 321114833
• Report Number: 3003306248-2023-05052
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2024
• Device Model Number: 100174772
• Device Lot Number: 007558704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 69 KG