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

Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was burning smell coming from unit during heat cycle.No patient was involved.
Additional Manufacturer Narrative
From the information provided, there is no indication that there was any device malfunction or nonconformance, 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.Field service engineer (fse) evaluated the device on-site, inspected the dialysate actuator (da) board and observed burn damage.Review of the provided images confirmed localized thermal damage on the da board, including charring and discoloration consistent with an electrical or thermal event.The fse replaced the da board and cat5 connector, performed a full-service rinse, and successfully completed a 15-minute mock treatment.Based on the available evidence, the investigation confirmed thermal damage to the da board; however, the specific root cause of the failure could not be determined from the visual inspection and 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: 50503257
• Report Number: 3010355846-2026-00095
• Device Sequence Number: 10088089
• Product Code: KDI
• UDI-Device Identifier: 00850001011204
• UDI-Public: (01)00850001011204(11)201214
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/28/2026

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
• 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: 08/01/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2020
• 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
• Patient Sex: Unknown