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

Catalog Number	PN-0006000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unintended Loss of Vascular Access (4867)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tablo instructions for use (ifu) warning and caution: the low venous pressure alarm may not occur with every disconnection or needle dislodgement.Check all blood lines for leaks after the treatment has started.Keep access sites uncovered and monitored.Improper blood line connections or needle dislodgements can result in excessive blood loss, serious injury, and death.System alarms may not occur in every blood loss situation.Outset medical, inc.Technical service engineer (tse) reviewed the system log for the procedure performed on (b)(6) 2026 and confirmed that the console functioned as intended.No issues or abnormalities were identified in the system performance.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
An (b)(6) male patient with end-stage renal disease on palliative care underwent hemodialysis.During treatment, the venous needle became dislodged, leading to significant blood loss.The patient remained alert and oriented but developed hypotension secondary to exsanguination.Medical staff initiated saline boluses and administered blood transfusion.The patient was transferred from the medical-surgical unit to the intensive care unit for further care.No alleged malfunction of the device was reported.The patient expired the following morning.

• 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: 24316113
• Report Number: 3010355846-2026-00015
• Device Sequence Number: 17362202
• Product Code: KDI
• UDI-Device Identifier: 00850001011204
• UDI-Public: (01)00850001011204(11)231218
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/11/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PN-0006000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male