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

Model Number PN-0003000

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

Patient Problem Loss of consciousness (2418)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the machine was evaluated at its location post treatment and was found to function as expected.Investigation of the device history record did not indicate any deviations or nonconformances during the manufacturing process.The log file review concluded events to be consistent with access issues.There was no indication that the device malfunctioned based on evaluations and feedback from hospital staff.The event is believed to be related to the patient's pre-existing conditions.

Event Description

It was reported that less than ten minutes into treatment, the patient lost consciousness.The patient started to desaturate into the low 80s, the heart rate rose into the 120s, while the blood pressure appeared to remain stable.Attempts made to wake the patient were unsuccessful and the patient remained unresponsive.The blood was rinsed back.It took the patient approximately five minutes to regain consciousness after the event occurred.The patient was placed back on a ventilator to help with oxygenation and his heart rate stabilized.It was reported that the patient is morbidly obese and very ill.The patient has a tunneled dialysis catheter in his chest; has a tracheostomy and was tachypneic prior to the dialysis treatment as he is recovering from acute respiratory failure and being on extracorporeal membrane oxygenation (ecmo).The patient had been on continuous renal replacement therapy (crrt) prior to this treatment.The patient was reported to be asymptomatic upon regaining consciousness (other than baseline tachypnea).The treating physician does not believe that the event was device related, rather, it was related to the patient's 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 (Section G): 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: 8688663
• MDR Text Key: 147724150
• Report Number: 3010355846-2019-00004
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)181227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PN-0003000
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2018
• 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; Required Intervention
• Patient Age: 22 YR