MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO 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 Problem Death (1802)

Event Date 11/14/2020

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 support specialist (tss) has reviewed site system logs with a procedure date of (b)(6) 2020.No related system alarms were found to have occurred during treatment.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 during a 12 hour dialysis treatment, the patient passed away.It was reported that the patient had multiple unspecified medical problems and was in bad health conditions before starting dialysis treatment on tablo.Per the information received from the customer, this event is attributed to the patient's pre-existing condition.

Manufacturer Narrative

Please note that the following section was updated with additional information received on 15-dec-2020: b7: other relevant history, including preexisting medical conditions.G3/4: date received by manufacturer.

• 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
• MDR Report Key: 11009462
• MDR Text Key: 221447473
• Report Number: 3010355846-2020-00033
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190426
• Combination Product (y/n): N
• PMA/PMN Number: K190793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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
• Distributor Facility Aware Date: 11/16/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death