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

Device Problems Use of Incorrect Control/Treatment Settings (1126); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse 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 and console operated as intended.Furthermore, clinical team met with staff and this issue has been determined to be a user issue, 0k acid used but prescription was set to 1k.Due diligence was completed, and outset was not able to confirm causality due to lack of information.A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product.This mdr is being filed after the associated complaint was reviewed under retrospective review and reassessed as reportable.

Event Description

It was reported that there was low dialysate conductivity error an hour and half into treatment and blood was unable to return to the patient.The patient lost approximately 220 ml of blood and patient is not stable due to missing a circuit of blood.Treatment started again on another tablo console.It is not believed that the tablo device caused the event; rather, the treating staff attributed the event to use error.Note: currently, it is unknown whether or not the device may have caused or contributed to the patient event; however, patient was unstable to begin with, patient was critically ill and an icu patient.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• Type of Device: 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: lance mattoon ; 3052 orchard drive; san jose, CA 95134 ; 6692318200
• MDR Report Key: 17515674
• MDR Text Key: 321050858
• Report Number: 3010355846-2023-00093
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other