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 Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

On (b)(6) 2020, vv ecmo procedure was started due to hypoxia refractory to conventional mechanical ventilation as part of covid19 bilateral pneumonia.Arterial cannula 21f was placed in v.Jugularis dex.And venous cannula 23f in v.Femoralis dex.The intervention passed without complications.On (b)(6) 2021 was the first time the hls set was replaced due to the fact that on that day there was a drop in spo2 to 50% with a sharp rise in delta pressure to 60mmhg and the value of pao2 in ecmo out gas analysis at 8kpa.On (b)(6) 2021 delta pressure reaches a value of 80mmhg, at which point the saturation in the patient is 92% and pao2 ecmo out 49kpa.In the next 4 hours the delta pressure progressively rises to 181mmhg with a drastic drop in saturation of up to 20%.In the complete blood count of platelet values 32 x 10 ^ 9 / l, aptt-r in the therapeutic range for heparin dosing on ecmo.The hls set was replaced again.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the delta pressure increased during treatment as the blood saturation decreased.It was reported that the patient was infected by covid-19.The production records of the affected hls module were reviewed on 2021-05-28.According to the final test results, all oxygenators passed the test as per specifications.Production related influences can be excluded.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.The most probable root cause for the reported failure could be determined as clots which can lead to a blockage and thus an extension of the diffusion path lowering the oxygenating 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 manager medical affairs the following events can contribute to clotting in the circuit: 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 plateles, (consumption) coagulopathy, thrombozytopenia.Based on the investigation results the reported failure "delta pressure increase" 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: 11300589
• MDR Text Key: 230955408
• Report Number: 8010762-2021-00104
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: 70104.7753
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 37 YR