It was reported that during patient treatment the po2 decreased to 56.
The product was exchanged - the patient was moved from cardio help to centragmag and quadrox.
The patient was stable.
As the product in question is contaminated with the coronavirus sars-cov-2 it was not requested to be returned by the customer due to the high risk of spreading the virus.
Therefore, no laboratory investigation could be performed by the manufacturer.
A device history record review of the affected oxygenator was not possible as no serial number could be obtained from the customer.
A device history record review of the oxygenator batch (lot 70138328) was performed with the following outcome: the dhr for the hls module advanced adult (material: 70105.
4378, lot: 70138328 dms#: (b)(4)) for which a customer complaint was received, was reviewed on 2020-10-15.
The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.
The reported failure was already investigated in similar complaint # (b)(4) with the following results: results of laboratory investigation: during optical inspection heavy clotting was detected in the oxygenator.
No leaks were noticed during the leak test carried out according to lv 201.
No pressure abnormalities or leaks were detected during the functional test using the cardiohelp.
The hls set worked according to its specifications.
Furthermore a dhr review was performed in regard to similar complaint # (b)(4).
No abnormality, or issue was found that is related, or can have led to the customer complaint.
Based on the similar complaint, investigation the reported failure could be confirmed but was not be attributed to a device related malfunction.
The most probable root cause of the reported event could be coagulation.
Due to the impaired blood flow the oxygenation performance of the oxygenator was decreased.
According to the ifu hls set advanced 5.
0 / 7.
0 1.
6 / g-670/ 02 chapter 4.
2 safety instructions for the extracorporeal circulation following causes could led to coagulation: no anticoagulation, or insufficient anticoagulation causes occlusion of the extracorporeal circulation, and the patient circuit.
This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.
Weigh the benefits of extracorporeal circulation against the risk of systemic anticoagulation.
Use anticoagulants; e.
G.
Heparin or argatroban.
Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).
Ensure that the act value does not fall below the value which is appropriate for the application.
Check the coagulation status of the patient's blood regularly.
The protocol for coagulation management is the responsibility of the user in charge.
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 regarding the above complaint is below the acceptance rate.
Thus, no remedial action 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.
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