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	Calibration Problem (2890)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144); Chills (2191)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer site dialysis nurse manager reported that a patient went to the emergency room following hemodialysis therapy on tablo.The following details were provided.The patient experienced nausea, vomiting, and chills, 1.5 hours into treatment.Vitals were fine.Patient asked to be taken off treatment.Following treatment, the patient was sent to the emergency room where it was determined that the patient had elevated white blood count.The customer site ran all tests for infection: covid and flu; all came back negative.The patient received 1g of vancomycin and 2g of fortaz and the patient reported symptom relief following the administration of vancomycin.The patient was later discharged home.Additionally, it was reported that the patient involved is doing fine and has received dialysis treatments since the incident on another tablo device without a recurrence of events.
Additional Manufacturer Narrative
As a containment action, the affected device was isolated and inspected by outset field service engineering.An investigation was performed on the machine, which determined that the acid and bicarbonate lines were misrouted, and the conductivity sensor was calibrated incorrectly.A capa was opened as a result of this complaint investigation.As a correction, the machine was repaired and verified to be working correctly.The investigation was expanded by reviewing the calibration data of conductivity sensors in the field and by reviewing complaint records and corresponding service records for the past 24 months.These reviews concluded that no other devices were identified with incorrect calibration data, and this was an isolated, one-time event.The capa investigation is in process and additional actions will be taken upon conclusion of the investigation.A review of production records for this serial number did not note any related manufacturing nonconformance's that would contribute to 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: 21883447
• Report Number: 3010355846-2025-00002
• Device Sequence Number: 7899438
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)201021
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/22/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown