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.
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It was reported that 5 hours and 46 minutes into a 12-hour sustained low-efficiency dialysis (sled) treatment, the patient coded.
It was reported that the patient was covid positive and had pneumonia.
Care personnel initiated cardiopulmonary resuscitation (cpr), ended treatment and blood was returned to patient.
The patient was pronounced at 18:36 same day.
The patient was not connected to the tablo device at the time of death.
To note, treatment started 11:25am and lasted after 5 hrs, 46mins and the patient was pronounced at 18:36 (6:36pm).
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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