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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problems Restricted Flow rate (1248); Gradient Increase (1270)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Further patient data and perfusion protocol were requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that the hls set used on a covid patient treated for ards had a delta pressure increase from 15 mmhg to 122 mmhg, with decreased flows to less than 2.0 lpm.Act at that time was 268 s.As the patient saturation dropped the circuit was changed after 2 h of initiation.Patient did not suffer any complication due to desaturation and stabilized after the circuit exchange.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the delta pressure of a hls module increased.The device was being used for treatment.The hls set was not available for investigation.However patient data was requested and analysed by getinge medical affairs.The patient was infected with covid-19.As stated by the getinge medical affairs team and in reference to available literature [1] 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 may be the result of a combination of processes driven by covid-19 occurring in synergy with the known effect(s) of the extracorporeal circuit on the coagulation system.Reference: [1] 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 in the absence of further data (patient data, technical investigation) and based on the covid-19 infection the most probable root cause for the reported failure was determined as clot formation in the extracorporeal circuit which 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: 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 hls module (fauf#102112420, po#102112420 and fauf#102112413, po#102112413) were reviewed on 2021-09-28.According to the final test results, the oxygenator with the serial# 1800995 passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on this the reported failure "delta pressure increased" could be confirmed.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.H3 other text : 4114.

• 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: 12171590
• MDR Text Key: 261644443
• Report Number: 8010762-2021-00395
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62