From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The device is functioning post treatment.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.A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product.
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It was reported that a patient coded and expired during a dialysis treatment.It was reported that the patient was critically ill, desaturated and had a cardiac arrest (v tach) due to multi-organ failure.The treatment was ended early and the patient expired after the acls protocol was initiated.Per the information received from the customer site, the patient death was unrelated to the tablo device, rather they attributed it to the patient's pre-existing condition.
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