MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Catalog Number PN-0000850

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss Of Pulse (2562)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

The tablo system log files were reviewed and showed some arterial pressure alarms during treatment, which is typical with patients that have permanent catheters in place as well as having blood pressure fluctuations.The system was evaluated in the facility and there were no issues observed.A mock treatment on the system was conducted successfully on 27 nov 2018.Based on the analysis and the information provided, this event does not appear to be device related, rather related to the patient's pre-existing conditions.

Event Description

It was reported that a patient receiving dialysis treatment became unresponsive with four minutes remaining in the treatment.The healthcare professional on the scene could not feel a pulse, started cpr, called 911 and removed the patient from the machine.The patient regained consciousness and was awake and alert.The blood was returned successfully.The patient was admitted to the er, evaluated and released.Based on the assessment, it was determined that the event may have been attributed to hypotension and therefore, related to the patient's pre-existing conditions.The system was checked and there was no blood leak detection alarm, there was no air in lines and no apparent leaks within the extracorporeal system or clotting noted.Based on this analysis and the information provided, this event does not appear to be device related, rather related to the patients pre-existing conditions.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 1830 bering drive; san jose CA 95112 4212
• Manufacturer Contact: jennifer mascioli-tudor ; 1830 bering drive; san jose, CA 95112-4212 ; 6692318235
• MDR Report Key: 8176901
• MDR Text Key: 130781441
• Report Number: 3010355846-2018-00002
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PN-0000850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 81 YR