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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 Problems Partial Blockage (1065); Improper or Incorrect Procedure or Method (2017)
Patient Problems Renal Failure (2041); Respiratory Distress Syndrome of Newborns (2046)
Event Date 01/14/2022
Event Type  malfunction  
Event Description
Patient is on tablo dt to akf. The tablo continued to clot off and system was changed multiple times. Patient was placed on heparin gtt. And order was placed to flush tablo system every hour to prevent it from clotting. Night rn did not flush system but instead bolused the patient every hour. Flushes are calculated in i/o and removed while boluses are not. Patient ended up receiving 1. 2l of fluid that was not accounted for during dialysis fluid removal. Provider was notified and changes are being made to fluid removal goal. Patient admitted for pres, developed ards and arf while hospitalized. She required trach and tablo. Rn may not have understood the difference between flushes and boluses on tablo clarifying with staff regarding the difference.
 
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 Key14249952
MDR Text Key290389662
Report Number14249952
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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