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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-0006000
Device Problems Device Emits Odor (1425); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2021
Event Type  malfunction  
Event Description
Patient was undergoing hemodialysis when the tablo had a water module failure. The tablo instructed the user to rinse the patient back, which was done. The module was changed out, and the failure occurred again. The user called tablo. Tablo attempted to remotely troubleshoot. While this was occurring, the user smelled smoke. The device was disconnected and shut off. Another tablo was obtained, and the patient's hemodialysis was completed without further incident. No untoward patient effects. Manufacturer response for dialyzer, high permeability with or without sealed dialysate system, tablo(r) hemodialysis system (per site reporter). Outset medical came to facility to evaluate the tablo.
 
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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 Key13051595
MDR Text Key282557213
Report Number13051595
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 Risk Manager
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPN-0006000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2021
Event Location Hospital
Date Report to Manufacturer12/21/2021
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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