MAUDE Adverse Event Report: Outset Medical, Inc. Tablo Hemodialysis System; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	PN-0003000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2026
Type of Reportable Event	Death
Event or Problem Description
A 67-year-old female patient who was ventilator and in critical condition underwent dialysis treatment.Treatment was initiated at approximately 1215 hours.During treatment the patient coded, blood was successfully returned to the patient, cardiopulmonary resuscitation (cpr) performed, including administration of sodium bicarbonate despite these efforts, the patient expired.
Additional Manufacturer Narrative
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.An outset medical, inc.Technical service engineer (tse) has reviewed site device logs with a procedure date of (b)(6) 2026, no related system alarms were found to have occurred during treatment.Additionally, cross functional review of the treatment logs and event description confirmed normal device operation and did not identify any anomalous system activity that could have contributed to the reported event.Based on the available evidence, no device-related failure was identified.A review of production records for this serial number did not note any related manufacturing nonconformances that would contribute to this event.

• Brand Name: Tablo Hemodialysis System
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): Outset Medical, Inc.; 3052 orchard drive; san jose CA 95134
• Manufacturer (Section G): Outset Medical, Inc.; 3052 orchard drive; san jose CA 95134
• Manufacturer Contact: dinamarie stefani ; 3052 orchard drive; san jose, CA 95134 ; +1(669)231-8200
• MDR Report Key: 50620879
• Report Number: 3010355846-2026-00104
• Device Sequence Number: 10525754
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)200828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 67 YR
• Patient Sex: Female