MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number	M25169L04S01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3/h6: 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.Tablo cartridge instructions for use (ifu) warning: if the cartridge does not mate correctly with the tablo hemodialysis console, there is possibility of air entering the extra-corporeal circuit, which may result in patient injury or death.Follow the user manual setup instructions for locking the cartridge on the console front panel.Investigation was performed via log file review.The investigation confirmed that an air in line alarm presented, and the machine operated as intended.There were no console related issues noted in the log file.Although a cartridge leak was reported, it was not able to be determined if the cartridge malfunctioned.A review of production records for this lot/serial number did not note any related manufacturing nonconformances that would contribute to this event.
Event or Problem Description
It was reported that there was air in line and blood leak during treatment.Treatment was discontinued, resulting in the loss of two full circuits of blood.A third cartridge from a different lot number was used with no issues observed.The patient subsequently received a double dose of epogen the following week per physician direction, then resumed the normal dose after hemoglobin dropped by one point.

• Brand Name: TABLO HEMODIALYSIS SYSTEM, TABLO 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 ; 6692318200
• MDR Report Key: 23403978
• Report Number: 3010355846-2025-00013
• Device Sequence Number: 15632763
• Product Code: KDI
• UDI-Device Identifier: 10850001011270
• UDI-Public: (01)10850001011270(10)261231(17)M25169L04S01
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: M25169L04S01
• 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: 10/08/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female