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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); Leak/Splash (1354)
Patient Problem Low Oxygen Saturation (2477)
Event Date 01/14/2022
Event Type  malfunction  
Event Description
Patient¿s mother repeated entry/exits into room interrupted treatment device troubleshooting by causing staff to stop troubleshooting so that patient could enter/exit the room. Patient was experiencing high % trach leak causing desaturation and experiencing tablo treatment tubing obstruction causing interruption of hd. Repeated entry and exit into patient's room while troubleshooting devices could have caused patient deterioration related to device issues and/or dislodging of iv/airway equipment from moving devices to let mother in and out. Since mother voluntarily left room while issues were actively being troubleshooted, staff asked that patient mother await outside of unit upon trying to reenter while the issues with patient devices were addressed and solved and patient became stable. Visitor should receive instruction on the potential safety issues caused by repeated exit/entry during staff troubleshooting and during patient deterioration.
 
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 Key14249912
MDR Text Key290385335
Report Number14249912
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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