• 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 PN-0003000
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/31/2021
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. Outset medical, inc. Field service engineer (fse) 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 system correctly identified and triggered arterial pressure low alarm three hours into treatment; blood pump stopped and all other components responded accordingly. The console is operating as intended after the event. 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 the blood pump was stopped due to low arterial pressure alarm during patient's treatment. It was reported that the nurse did not attend or intervene for the low arterial pressure alarm and it went on for 20 minutes. Treatment was ended and patient's blood was discarded. The patient lost approximately 1 l of blood. Note 1: it was reported that the patient's venous needle became dislodged and the patient was transferred to the intensive care unit (icu), and was reported to be unstable. No further patient information is available. Based on internal review of the log file data, it is not believed that the tablo device caused this event, rather this is attributed to user error.
 
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 Key11378448
MDR Text Key233520351
Report Number3010355846-2021-00057
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPN-0003000
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 Date02/01/2021
Event Location No Information
Date Manufacturer Received02/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/25/2021 Patient Sequence Number: 1
-
-