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

Model Number PN-000300

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

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 12/13/2020

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 team, has reviewed site system logs with a procedure date of (b)(6) 2020, 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 20 minutes into a 12-hour sustained low-efficiency dialysis (sled) treatment, the medical personnel ended treatment due the patient being hypertensive and unable to tolerate dialysis.As a result, the treatment was stopped and the patients blood was returned successfully.It was reported that approximately one-hour post treatment, the patient expired.The patient was not connected to the tablo device when this event occurred.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.Note 1: the patient was hypertensive prior to initiating the dialysis treatment.Note 2: another event was reported on this same patient that occurred on a different day (refer to mdr # 3010355846-2021-00042).

• 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
• Manufacturer (Section G): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• Manufacturer Contact: 6692318235
• MDR Report Key: 11156954
• MDR Text Key: 226520706
• Report Number: 3010355846-2021-00045
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)200831
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PN-000300
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/13/2020
• Initial Date Manufacturer Received: 12/13/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• 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
• Patient Age: 65 YR