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

Model Number BE-HLS 5050 #SHLS SET ADVANCED 5.0

Device Problem Decrease in Pressure (1490)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6) during patient treatment.It was reported that the oxygenation of the be-hls 5050 #shls set advanced 5.0 was low and a pressure drop occurred.The ecmo therapy was continued due to the exchange of the hls set with the hls 5.0 membrane system.After the exchange, they noticed an improvement of the oxygenation.The patient was infected with covid-19.The customer scrapped the affected be-hls 5050 #shls set advanced 5.0 therefore a technical investigation could not be performed at the getinge laboratory.The patient was infected with covid-19.As stated by the getinge medical affairs team and in reference to the literature covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.The increased risk of thrombosis and coagulopathy in ecmo patients is a result of a combination of processes driven by the disease occurring in synergy with the effect of the extracorporeal circuit on the coagulation system.In the absence of data and based on covid-19 as the most probable root cause for the reported failure, clot formation in an extracorporeal circuit can lead to a reduction and/or blockage, and thus, an reduction of the diffusion path lowering the gas transfer performance.With reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v26) and in consultation with the getinge manager medical affairs team the following events can contribute to clotting in the circuit: air remains in or enters the circuit inappropriately low, or no blood flow, in the circuit improper hemostasis too low anticoagulation too low act level, effect of heparin is too limited protamine sulfate enters the hls set administration of congealable substances (such as platelets) or pro-coagulant medications.(consumption) coagulopathy.The production records of the affected be-015503112 #shls mod advanced small ad was reviewed on (b)(6) 2022.According to the final test results, all be-015503112 #shls mod advanced small ad passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the investigation results the reported failure "oxygenation was low and a pressure drop occurred" could be confirmed.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 yusuff h, zochios v, brodie d."thrombosis and coagulopathy in covid-19 patients requiring extracorporeal membrane oxygenation" asaio j.2020;66(8):844-846.Doi:10.1097/mat.0000000000001208.

Event Description

The event occurred in (b)(6) during patient treatment.It was reported that the oxygenation of the be-hls 5050 #shls set advanced 5.0 was low and a pressure drop occurred.The ecmo therapy was continued due to the exchange of the hls set with the hls 5.0 membrane system.After the exchange, they noticed an improvement of the oxygenation.The patient was infected with covid-19.Complaint-id:(b)(4).

• Brand Name: HLS SET ADVANCED
• 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: 13950815
• MDR Text Key: 288272087
• Report Number: 8010762-2022-00105
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2022
• Device Model Number: BE-HLS 5050 #SHLS SET ADVANCED 5.0
• Device Catalogue Number: 701069076
• Device Lot Number: 3000161070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 95 KG