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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO(R) HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Lot Number 21NU06006
Device Problem Improper Flow or Infusion (2954)
Patient Problem Cardiac Arrest (1762)
Event Date 02/05/2022
Event Type  Death  
Event Description
Completed 22 hour run on patient. While attempting to get the machine running for subsequent treatment, there were several errors where the key was not allowing up to run tablo. Nursing was instructed to remove the key and try saving the prescription to the tablo vs the key. During the time it took to get supplies and troubleshoot the machine the patient experienced a cardiac arrest. It took three filter and cartridge sets and two machines to finally get it running again. The whole experience lasted approximately 8 hours to begin a successful run from when the initial tablo run was completed. Unknown if delay in treatment due to equipment contributed to cardiac arrest and ultimate death.
 
Event Description
No equipment issues or human factors interacting with equipment identified.
 
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Brand NameTABLO(R) 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
MDR Report Key14013754
MDR Text Key288595655
Report Number14013754
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number21NU06006
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/09/2022
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer04/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/05/2022 Patient Sequence Number: 1
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