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

Catalog Number	PN-0006000
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a low water pressure alarm and burning smell coming from the device during pre-treatment cycle.No patient was involved.
Additional Manufacturer Narrative
An outset medical, inc.Field service engineer (fse) evaluated the device on-site, inspected the ultrafilter pump (ufp) and identified damage to ufp during inspection.Therefore, fse replaced the ufp, performed rinse service rinse, and successfully placed console in chemical disinfection.Based on the available evidence, the investigation confirmed thermal damage to the ufp; however, the specific root cause of the failure could not be determined from the available information.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: 50863447
• Report Number: 3010355846-2026-00133
• Device Sequence Number: 9314418
• Product Code: KDI
• UDI-Device Identifier: 00850001011204
• UDI-Public: (01)00850001011204(11)230609
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PN-0006000
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• 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
• Patient Sex: Unknown