It was reported that the customer noticed blood on the lower tray below the hls set.
Blood seems to be slowly leaking from the venous side of the membrane oxygenator.
Otherwise, everything is functioning as it should per customer.
The patient is being weaned off support.
The patient was ready to come off support regardless of the leak.
There was no patient harm, and the patient was weaned off successfully.
The patient was covid positive, so the hls disposable was disposed of.
The affected product was not available for technical investigation of the manufacturer.
Thus the exact root cause of the reported event could not be determined.
The production records of the affected hls module (3000159544) were reviewed on 2021-11-22.
Following steps are performed according to the bop with a 100 % inspection: tightness test water side, tightness test blood side, final product test.
According to the final test results, the oxygenator with the serial# (b)(4) passed the tests as per specifications.
No previous complaint with an associated laboratory investigation was found.
No picture or video was provided.
Thus the reported failure "blood leakage from venous side" could not be confirmed.
However the following most probable causes of the reported failure "blood leakage from venous side" are know according to our risk assessment hls set advanced (dms# (b)(4): mechanical damage to the connector during connection, blood tubing is damaged, damaging of connectors during removing of caps.
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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It was reported that the customer noticed blood on the lower tray below the hls set.
Blood seems to be slowly leaking from the venous side of the membrane oxygenator.
Otherwise, everything is functioning as it should per customer.
The patient is being weaned off support.
The patient was ready to come off support regardless of the leak.
There was no patient harm, and the patient was weaned off successfully.
The patient was covid positive, so the hls disposable was disposed of.
Complaint id: (b)(4).
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