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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient became symptomatic during treatment.The nurse stated that the console was initially set to remove a 2000ml goal but was adjusted to 1850ml due to the patient feeling unwell.However, after weighing the patient, the nurse alleged that 3300ml had actually been removed, while the console indicated only 1850ml was removed.The patient experienced severe cramps and chest pain, leading to transportation to the emergency room.
Additional Manufacturer Narrative
H3/h6: from the information provided, there is no indication that there was any device malfunction or nonconformance, that contributed to the reported event.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.Outset medical, inc.Field service engineer (fse) was dispatched to the customer site to further investigate the reported issue.Fse found no issue with the console.Furthermore, system engineer reviewed site system logs with a procedure date of (b)(6) 2024 and determined that the connections were pressure tested prior to treatment and verified not to leak at that time.Additionally, a leak of over 1000ml would have been obvious to the user, so a leak of this magnitude is unlikely.Through log file review, the two dialysate pump flow rates were verified to be controlled as expected.Therefore, through the verification of the pump rates, it can be concluded that the system removed 1850ml +/- 305ml.There was no issue with the system which caused the patient event.A review of production records for this serial number did not note any related manufacturing nonconformances 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: 20909892
• Report Number: 3010355846-2024-00106
• Device Sequence Number: 20977656
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)201013
• 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): 12/11/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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 Age: 86 YR
• Patient Sex: Female
• Patient Weight: 52 KG