Update 03/18/2016 02:05 pm (b)(4): maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).
The product was scrapped by the hospital; therefore manufacturer laboratory investigation was not possible.
The complaint was determined to be potentially related to the medical device recall notice for hls set advanced dated february 23, 2016 in the us.
This data will be handled trough a designated maquet trending process.
If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.
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The quadrox-id oxygenator was returned to the factory and investigated.
Due to the product being contaminated, only a visual inspection could be carried out.
No blood clots were visible on either the blood inlet or outlet side of the oxygenator.
The serial number / udi and the lot number of the oxygenator were photographically documented.
Due to the high risk of infection posed by the disposable, it was disposed off appropriately after the visual inspection.
The conclusion was that no clotting or any other anomalies could be established.
A clinical assessment of this issue was carried out by the director for clinical risk management & documentation.
Taking all the available information into account, he concluded that there is no indication that endotoxins from a maquet oxygenator is related to the state of the patient due to the following facts: 1)the patient had developed endocarditis prior to admission of the hospital.
2)elevated levels of d-dimers and fibrinogen is a typical finding in patients suffering from severe infections.
3), after the heart valve (source of infection) was resected and a new valve was placed, the patient recovered.
Note: without ecmo and heart surgery, the patient would probably not have been able to survive; this was a successful treatment of an extremely sick patient.
A correlation between elevated acute phase proteins and the maquet oxygenator cannot be confirmed.
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