MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that an hls module clotted during use.Complaint (b)(4).

Manufacturer Narrative

It was reported that an hls module clotted during use.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 the product was discarded by the customer, therefore a technical investigation of this hls set is not possible at the laboratory of maquet cardiopulmonary gmbh.The reported clots lead to a blockage and thus an increased delta pressure and reduced flow.According to our risk management file (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4), v26) following most possible root causes can lead to clotting: -de-airing luer lock connection too loose.-air remains in or enters the circuit.-hemostasis.-air or blood remains in luer lock access port.-too low anticoagulation.-too low at level, effect of heparin is too limited.-protamine sulfate enters the hls set.-administration of substitution of congealable substance such as platelets.-(consumption) coagulopathy.-thrombozytopenia.The production records of the affected hls module were reviewed on 2021-06-21.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, the oxygenator with serial number (b)(6) passed the test as per specifications.Production related influences are unlikely.Based on these investigation results and the given information the reported failure 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.

Event Description

Complaint #(b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11692675
• MDR Text Key: 246242807
• Report Number: 8010762-2021-00260
• 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: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753 (HLS SET)
• Device Lot Number: 70134502 (HLS MODULE)
• Date Manufacturer Received: 06/16/2021
• Patient Sequence Number: 1