• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OUTSET MEDICAL, INC. TABLO X HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number TABLO X HEMODIALYSIS SYSTEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 10/20/2021
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. 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.
 
Event Description
It was reported that a (b)(6) male patient coded during treatment due to a cardiac arrest. The treatment started at 9:34 am and the patient coded at 7:01 pm. The clinical staff was able to end treatment, return blood and perform cpr. The patient was resuscitated and then was intubated. Post-treatment, the family then decided to extubate, and the patient expired. It was reported that the patient condition prior to treatment was critical, he was an icu patient and was septic. The clinical staff believes that this event is likely patient related, due to the critical icu patient condition, however, they were not able to confirm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTABLO X HEMODIALYSIS SYSTEM
Type of DeviceDIALYZER, 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 Key12837047
MDR Text Key280964063
Report Number3010355846-2021-00072
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190793
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTABLO X HEMODIALYSIS SYSTEM
Device Catalogue NumberPN-0003000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/21/2021
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/18/2021 Patient Sequence Number: 1
-
-