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

Model Number PN-0003000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 03/18/2021

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. Technical team has reviewed site system logs with a procedure date of (b)(6) 2021, and verified that there was no issue with the system which caused the patient event. The device is functioning post treatment. A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product event.

Event Description

It was reported that a patient who was covid-19 positive coded during a dialysis treatment. It was reported that the patient was previously dialyzed twice due to high potassium and catheter not being operable. During the first treatment setup, machine was treating but due to catheter issues the treatment was ended and care personnel conducted a new catheter placement. Approximately 44 minutes into a second treatment setup, the patient showed continued decline in blood pressure, then progressed into bradycardia and asystole. Code blue was called, blood was returned and protocols were followed, including cardiopulmonary resuscitation (cpr) and medications. Treatment was not resumed because patient remained too unstable for dialysis treatment. Based on the information provided, the clinical staff does not believe that the tablo device caused the event rather this event was attributed to the patient's pre-existing conditions.

• Brand Name: TABLO X 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: 6692318235
• MDR Report Key: 11669708
• MDR Text Key: 245630159
• Report Number: 3010355846-2021-00067
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PN-0003000
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 03/18/2021
• Event Location: No Information
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/15/2021 Patient Sequence Number: 1