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

Model Number BE-HLS 7050 #HLS SET ADVANCED 7.0

Device Problem Increase in Pressure (1491)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

Event Type  Death  

Manufacturer Narrative

The getinge service and sales unit reported on 2021-06-16 that the patient deceased in relation to the illness severity and not in relation to a product malfunction.Further information has been requested but is pending.The investigation is ongoing.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The following was reported "patient was placed on ecmo.The delta p was high from beginning (50-60mmhg).After 13 days abg was taken from arterial line.Po2 was 50 mmhg.The ecmo circuit was changed.After discussion with the team some members report that sound of ecmo was different than usual.The patient was infected with covid".Note- additional information was provided by the ssu on june 16 2021 that the patient expired.Complaint #(b)(4).

Manufacturer Narrative

The following was reported "patient was placed on ecmo.The delta p was high from beginning (50-60mmhg).After 13 days abg was taken from arterial line.Po2 was 50 mmhg.The ecmo circuit was changed.After discussion with the team some members report that sound of ecmo was different than usual.The patient expired.The patient was infected with covid-19.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.Due to the high risk of spreading the sars-cov-2 virus outside the healthcare environment and as the product was discarded of by the customer, a technical investigation of this hls set is not possible at the laboratory of getinge.A medical review was performed by getinge medical affairs on 2021-08-18 with following outcome: a definitive root cause cannot be attributed to the reported hls malfunction.Based on the correspondence and the given information in the complaint report, it cannot conclude there was a malfunction of the hls module.The report of a low po2 alone does not confirm an hls module malfunction.As a result, patient injury or death cannot be conclusively be attributed to hls module malfunction.A lack of co2 retention suggests gas exchange of the hls module remained functional.The module was used for support for a 13-day duration.Maximum approved application is for 30 days for veno-veno and veno-arterial support when bioline coated, and when used in combination with hls cannulae.The lack of supporting clinical metrics and a clinical record prevent the author from confidently proposing secondary or associated causes that contributed to the patient¿s outcome.This includes non-device related events such as the clinical pathology of covid 19 induced septic shock.Finally, the patient reportedly expired due to multi-organ failure because of septic shock that based on the correspondence developed or progressed following the successful discontinuation of ecmo.The cause of death is consistent with the natural course of end organ damage because of septic shock to the central nervous system, pulmonary, cardiovascular, and hematologic systems, in summary, it is not possible to attribute this outcome to low po2 values because of a hls module malfunction.There is simply no data to support this conclusion.It is equally not possible to attribute this outcome to overwhelming sepsis, clinical management/monitoring or use errors alone or in combination.The most probable root cause based on the information provided is the patient succumbed to refractory and overwhelming septic shock induced by covid 19.The production records of the affected hls module were reviewed on 2021-08-23.Following tests are performed according to the bop 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, all oxygenators passed the test as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on these investigation results and the given information the reported failure could be confirmed but no product related malfunction.The occurrence rate was calculated for the reported failure 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: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12016776
• MDR Text Key: 256723803
• Report Number: 3008355164-2021-00019
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #HLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073 (HLS SET)
• Device Lot Number: 3000145834 (HLS MODULE)
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2021
• Distributor Facility Aware Date: 08/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2021
• Date Manufacturer Received: 08/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Weight: 100