From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.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.Outset medical, inc.Technical team has reviewed site system logs with a procedure date of (b)(6) 2021, and verified that there was no issue with the system which caused the patient event.The device is functioning post treatment.A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product event.
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It was reported that a (b)(6) male patient coded during treatment due to a cardiac arrest.The treatment started at 9:34 am and the patient coded at 7:01 pm.The clinical staff was able to end treatment, return blood and perform cpr.The patient was resuscitated and then was intubated.Post-treatment, the family then decided to extubate, and the patient expired.It was reported that the patient condition prior to treatment was critical, he was an icu patient and was septic.The clinical staff believes that this event is likely patient related, due to the critical icu patient condition, however, they were not able to confirm.
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