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

Model Number TABLO X HEMODIALYSIS SYSTEM

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914); Septic Shock (2068); Virus (2136)

Event Date 01/24/2021

Event Type  Death  

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 Description

It was reported that a patient coded and expired during a dialysis treatment.The patient was admitted through the emergency department (ed) with septic shock, covid-19 and kidney injury.The care personnel reported that prior to treatment the patient was hypotensive, declined in ed and was intubated and continued to deteriorate in the intensive care unit (icu).The patient was on four vasopressors, sedated, intubated, and on iv fluids.It was noted that access was placed and the dialysis unit was called in to dialyze the patient knowing that the patient would not do well; however, the patient's family insisted.Per the information received from the customer site, the patient death was unrelated to the tablo device, rather they attributed it to the patient's pre-existing condition.

• 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: 11362997
• MDR Text Key: 233012487
• Report Number: 3010355846-2021-00054
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190702
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLO X HEMODIALYSIS SYSTEM
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/25/2021
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• 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): Death