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

Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tablo instructions for use (ifu) warning and caution: when the blood in dialysate alarm occurs, the dialysate must be tested for the presence of blood, and the system alarm screen prompt must be answered to clear the alarm.Follow the alarm screen instructions to sample the effluent dialysate, and test the sample as instructed by your center.The system will prevent treatment continuation in the event of the presence of blood in the dialysate.Always immediately contact your center in the event of a blood loss event.Outset technical support engineer (tse) reviewed the system log with the procedure date of (b)(6) 2026 and confirmed that the console is functioning as designed when a blood leak is detected.The reported event is related to the dialyzer, not the console.A review of production records for this serial number did not note any related manufacturing nonconformance's that would contribute to this event.
Event or Problem Description
It was reported that there was an alarm for dialyzer blood leak two times during treatment.Nurse confirmed positive blood leak alert/alarm that was verified as positive with the blood leak testing strips at the dialyzer.Approximately 600 ml of blood was lost.No patient adverse event was noted as a result of 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 ; 6692318200
• MDR Report Key: 24525160
• Report Number: 3010355846-2026-00027
• Device Sequence Number: 18273404
• Product Code: KDI
• UDI-Device Identifier: 00850001011204
• UDI-Public: (01)00850001011204(11)211015
• 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
• 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): 03/05/2026

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: 02/05/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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