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

Lot Number	M25342L06S01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction

• Brand Name: Tablo Hemodialysis System, Cartridge
• 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: 50233460
• Report Number: 3010355846-2026-00082
• Device Sequence Number: 16026544
• Product Code: KDI
• UDI-Device Identifier: 10850001011256
• UDI-Public: (01)10850001011256(17)270630(10)M25342L06S01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/12/2026

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 Lot Number: M25342L06S01
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown