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 Problems Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 05/26/2020

Event Type  Injury  

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.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 about one hour into treatment, the patient became hypotensive and coded.Treatment had to be terminated.There was no blood loss.Treatment was not resumed as the patient needed cardiopulmonary resuscitation (cpr) and other medical attention.Patient did survive the occurrence.This patient was a new start and the nephrologist was not sure how the patient would tolerate the dialysis treatment.The clinician ruled the tablo device out as the cause for the event.The unit operated as intended.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE 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: 6692318235
• MDR Report Key: 10189587
• MDR Text Key: 201022466
• Report Number: 3010355846-2020-00020
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00850001011112
• UDI-Public: (01)00850001011112(11)190812
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2019
• 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): Life Threatening; Required Intervention