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

Lot Number	M25309L04S01-1620
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a blood leaking from blood pump segment of cartridge during patient treatment.An estimate of 20ml of blood was lost.No patient adverse event was noted as a result of this event.
Additional Manufacturer Narrative
Tablo instructions for use (ifu) warning and caution: check all bloodlines for leaks after the treatment has started.Keep access sites uncovered and monitored.Improper bloodline connections or needle dislodgements can result in excessive blood loss, serious injury, and death.Machine alarms may not occur in every blood loss situation.The actual device was not returned; however, a photograph was provided for evaluation.Visual inspection of the photo did confirm a cartridge leak; however, the exact cause is unknown; therefore, specific root cause could not be determined.A review of production records for this lot number did not note any related manufacturing nonconformances that would contribute to this event.

• 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 ; 6692318200
• MDR Report Key: 25620198
• Report Number: 3010355846-2026-00059
• Device Sequence Number: 18696536
• Product Code: KDI
• UDI-Device Identifier: 10850001011256
• UDI-Public: (01)10850001011256(17)270531(10)M25309L04S01-1620
• 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): 06/25/2026

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: M25309L04S01-1620
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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