• 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 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 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 Death (1802)
Event Date 02/08/2020
Event Type  Death  
Manufacturer Narrative
Outset medical, inc. Systems engineer 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 a patient was experiencing low blood pressure during sustained low efficiency dialysis (sled) treatment. The display setting touchscreen went blank during treatment after changing the acid jugs and the nurse decided to end treatment three hours into a twelve hour treatment. The nurse was able to initiate "stop treatment" and return blood to the patient with no issues and no blood loss. It was noted that the patient had been experiencing low blood pressure issues pre-treatment in addition to during treatment. The tablo program specialist (tps) was notified two days later ((b)(6) 2020) that the patient passed away the evening of (b)(6) 2020, after treatment; however, death was noted to be due to the patient¿s pre-existing conditions and not related to the dialysis treatment or tablo unit.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTABLO HEMODIALYSIS SYSTEM
Type of DeviceDIALYZER, 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 Key9814263
MDR Text Key182890289
Report Number3010355846-2020-00014
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? Yes
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
Was the Report Sent to FDA?
Distributor Facility Aware Date02/10/2020
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2019
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: 03/10/2020 Patient Sequence Number: 1
-
-