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 patient who was covid-19 positive coded during a dialysis treatment.
It was reported that the patient was previously dialyzed twice due to high potassium and catheter not being operable.
During the first treatment setup, machine was treating but due to catheter issues the treatment was ended and care personnel conducted a new catheter placement.
Approximately 44 minutes into a second treatment setup, the patient showed continued decline in blood pressure, then progressed into bradycardia and asystole.
Code blue was called, blood was returned and protocols were followed, including cardiopulmonary resuscitation (cpr) and medications.
Treatment was not resumed because patient remained too unstable for dialysis treatment.
Based on the information provided, the clinical staff does not believe that the tablo device caused the event rather this event was attributed to the patient's pre-existing conditions.
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