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

Catalog Number	PN-0003000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3/h6: investigation was performed via log file review.The investigation confirmed that a blood in dialysate alarm presented, and the machine operated as intended.At this time the cause of the patient's blood loss is not likely to be related to tablo, however causality has not been confirmed.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.A review of production records for this 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 a blood dialysate alarm during treatment.Treatment was ended and the user noted that they discarded blood three times resulting in approximately 900ml blood loss.There was no patient complications reported.Multiple attempts were made by outset clinical specialist to obtain additional information; however, the customer did not respond.

• 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: 21170996
• Report Number: 3010355846-2025-00001
• Device Sequence Number: 4603931
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190627
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/16/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PN-0003000
• 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: 12/18/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2019
• 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: Other
• Patient Sex: Unknown