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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
Model Number PN-0003000
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2022
Event Type  malfunction  
Event Description
Tablo hemodialysis system gave a "prime test failure" during set up.The cartridge (lot #d2225709) was tried twice and failed both times.A new cartridge was gathered.The machine was set up again, at which time it passed all tests and we were able to proceed with the machine and the new set up.
 
Event Description
Tablo hemodialysis system gave a "prime test failure" during set up.The cartridge (lot #d2225709) was tried twice and failed both times.A new cartridge was gathered.The machine was set up again, at which time it passed all tests and we were able to proceed with the machine and the new set up.
 
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Brand Name
TABLO(R) HEMODIALYSIS SYSTEM
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL, INC.
3052 orchard drive
san jose CA 95134
MDR Report Key15843597
MDR Text Key304123393
Report Number15843597
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 11/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPN-0003000
Device Catalogue NumberPN-0003000
Device Lot NumberD2225709
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2022
Event Location Hospital
Date Report to Manufacturer11/22/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/22/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/23/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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