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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/13/2022
Event Type  malfunction  
Event Description
Tablo run started in evening, about 30 minutes later first alarm went off stating bypass valve failure and instructed us to press and release the power button to restart. After following those instructions new alarm of "bad dialysate conductivity" appeared and instructed us that the treatment must end and the blood to be discarded and to not manually return the blood. Following tear down a third alarm appeared on the screen that tablo requires technical support and to call outset technical support called outset technical support. She recommended switching out the machine as she couldn't see anything on her end that would result in the alarms. She also estimated the patient blood loss to 122ml will review tablo team meeting.
 
Event Description
No equipment issues or human factors interacting with equipment identified.
 
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Brand NameTABLO 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 Key14250011
MDR Text Key290389805
Report Number14250011
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 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2022
Event Location Hospital
Date Report to Manufacturer04/29/2022
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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