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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
Device Problems Defective Alarm (1014); Fluid Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/02/2022
Event Type  malfunction  
Event Description
Pt was running continuous renal replacement therapy (crrt) with tablo. Charge nurse walked by pt's room and noticed a puddle of blood below the tablo machine. No alarms were on. The top connection on the filter worked itself loose and was spilling blood. Medical icu resident was notified. Tablo was discontinued and a complete blood count was ordered and drawn 1 hour after incident and no significant changes in hemoglobin were noted.
 
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 Key13994640
MDR Text Key288502418
Report Number13994640
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
0 Patients were Involved in the Event:
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Manufacturer04/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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