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.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 dialysis treatment on a tablo device.It was reported that the patient was covid positive, was in critical care and had other aligning health issues.Per the information received from the customer site, it is not believed that the tablo device contributed to the patient expiration, rather this event was attributed to the patient's pre-existing condition.
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