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

Model Number BE-HLS 7050

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hemolysis (1886)

Event Date 09/11/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.(b)(4).

Event Description

It was reported that after 17 days of use the product was exchanged due to deterioration of performance.In the 48 hours following the change, there is an increase in hemolysis associated with an increase in pump revolutions, necessary to ensure adequate flow.It was therefore decided to replace the kit again with resolution of the problem both for number of revolutions and for decrease in hemolysis.No consequences for the patient.No harm was reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that after 17 days of use the product was exchanged due to deterioration of performance.In the 48 hours following the change, there is an increase in hemolysis associated with an increase in pump revolutions, necessary to ensure adequate flow.It was therefore decided to replace the kit again with resolution of the problem both for number of revolutions and for decrease in hemolysis.No consequences for the patient.No harm was reported.The affected product was investigated at the laboratory of the manufacturer.No damages were detected during visual inspection.Numerous clots were visible within the rotor pump and the blood inlet connector, furthermore the blood inlet side of the oxygenator was also clotted.A performed leakage test was passed without any abnormalities.During a function and flow check of the pump no abnormalities or noises were detected.The production records of the affected hls module (batch#3000218620, 3000217009, 3000211367 ) were reviewed.Following tests are performed 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.Furthermore a medical assessment of the provided event information was performed by getinge medical affairs with the following outcome: after the evaluation of the existing details, it is unclear what caused the increase of the hemolysis after change to the second hls.The following may be possible root causes for the reported event: a change of a of an extracorporeal circuit may result in increased hemolysis, inflammation, and consumption of formed blood elements as the new circuit represents a fresh foreign surface to the circulating blood volume.Increased resistance (seen as an increase in patient afterload) may result in the need for higher rpms to achieve the required blood flow for adequacy of perfusion.-the reported aptts appear to be below the recommended values for ecmo is to achieve a factor of 1.5 to 2.5 times above baseline.Lower than recommended aptts (for extracorporeal support) may have created a condition where clot/thrombus could form in a oxygenator membrane.Presence of thrombus inside the membrane of the hls set may have resulted in lower blood flows, which may have required higher than expected rpms to generate the requisite blood flow in the presence of thrombus.Finally, it remains to be stated that the hls set showed that no structural malfunction/defect or diminution in performance was detected via getinge testing of the product.Further the cause for the hemolysis reported in the complaint could not be determined.Thus the reported failure "increase in hemolysis" could be confirmed but was most probable not associated with or contributed by a product related malfunction.The exact root cause remains unknown.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the event.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.

• 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: 15593413
• MDR Text Key: 306685942
• Report Number: 8010762-2022-00404
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701069073
• Device Lot Number: 3000218620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1