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

Lot Number	M24192L03S01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
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.At this time the cause of these event is not clear, and causality has not been confirmed.No further information was received.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.Tablo cartridge instructions for use (ifu) warning: ensure all connections are secure before use and monitor for leaks regularly during patient use.Blood loss can result if connections are not secure and during the dialysis treatment, monitor the lines and check for leaks.Machine alarms may not occur in every blood loss situation.A review of production records for this lot number did not note any related manufacturing nonconformances that would contribute to this event.
Event or Problem Description
It was reported that there are hospital utilization of tablo dialysis machines and blood lines from lot numbers with known problems.Use of these products and equipment is exposing critically-ill patients to unnecessarily hazardous conditions involving risk of significant blood loss, hemolysis, air embolism, and systemic infection.Faulty blood lot lines are causing blood leaks internally and externally.Internal blood leaks are nearly undetectable, leading to an unknown level of contamination.Since machines are not patient-specific, individual patient exposure to potential blood borne pathogens, such as hepatitis b, is increased.Hospital use of expired acid baths for dialysis treatments and sharing of single-use dialysate baths between multiple patients when stock is low.

• Brand Name: TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE
• 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: alonso mendoza ; 3052 orchard drive; san jose, CA 95134 ; 6692318200
• MDR Report Key: 20457720
• Report Number: 3010355846-2024-00105
• Device Sequence Number: 20763009
• Product Code: KDI
• UDI-Device Identifier: 00850001011273
• UDI-Public: (01)00850001011273(10)260131(17)M24192L03S01
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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
• Device Expiration Date: 01/31/2026
• Device Lot Number: M24192L03S01
• 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: 09/16/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown