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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

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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 Use of Device Problem (1670)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/31/2020
Event Type  Death  
Manufacturer Narrative
From the information provided there is no indication that there was any device malfunction or nonconformance that contributed to the reported event. Multiple follow up attempts to gather additional information from the initial reporter were unsuccessful. 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) 2020 and (b)(6) 2020, and verified that the device was functioning as intended.
 
Event Description
Healthcare professional reported that a patient coded during treatment and that blood was leaking from the blue dialyzer connector. The patient expired the next day. The cause of the blood leaking from the blue dialyzer connector was reported to be due to operator error. The cause of death and relationship between the death and tablo was not provided.
 
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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
saket bhatt
MDR Report Key14190695
MDR Text Key289948517
Report Number3010355846-2022-00074
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 Consumer,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTABLO X HEMODIALYSIS SYSTEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/29/2022
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/22/2022 Patient Sequence Number: 1
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