From the information provided, there is no indication that there was any device malfunction or nonconformance, that contributed to the reported event.For the reported event (blood leaking from the dialyzer connection point), there is no sensor to indicate a leak, only visual observation.Potential adverse events in the instructions for use (ifu) with the tablo system includes, but are not limited to, other, more serious, complications arising from dialysis, such as hemorrhage, air embolism, acidosis, alkalosis or hemolysis, can cause serious patient injury or death.Tablo user manual has the following warning: ensure all connections are secure before use and monitor for leaks regularly during patient use.Blood loss can result if connections are not secure and during the dialysis treatment, monitor the lines and check for leaks.Machine alarms may not occur in every blood loss situation.Outset medical, inc.Technical support engineer (tse) reviewed site system log with a procedure date of 20-nov-2023 and verified that there was no issue with the system which caused the patient event.The dialyzer and cartridge were discarded; therefore, root cause of the event was not able to be confirmed, however is it not suspected to be product related.A review of production records for this cartridge lot did not note any related manufacturing nonconformances that would contribute to this event.
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It was reported that 2 hours and 45 minutes into treatment, patient coded due to loss of consciousness/breathing.The patient condition prior to treatment was stable, and the loss of consciousness/breathing was attributed to 750cc blood loss from the dialyzer.Medical intervention was performed, and the patient improved to stable condition.
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