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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Catalog Number PN-0000850
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Loss Of Pulse (2562)
Event Date 11/26/2018
Event Type  Injury  
Manufacturer Narrative
The tablo system log files were reviewed and showed some arterial pressure alarms during treatment, which is typical with patients that have permanent catheters in place as well as having blood pressure fluctuations. The system was evaluated in the facility and there were no issues observed. A mock treatment on the system was conducted successfully on 27 nov 2018. Based on the analysis and the information provided, this event does not appear to be device related, rather related to the patient's pre-existing conditions.
 
Event Description
It was reported that a patient receiving dialysis treatment became unresponsive with four minutes remaining in the treatment. The healthcare professional on the scene could not feel a pulse, started cpr, called 911 and removed the patient from the machine. The patient regained consciousness and was awake and alert. The blood was returned successfully. The patient was admitted to the er, evaluated and released. Based on the assessment, it was determined that the event may have been attributed to hypotension and therefore, related to the patient's pre-existing conditions. The system was checked and there was no blood leak detection alarm, there was no air in lines and no apparent leaks within the extracorporeal system or clotting noted. Based on this analysis and the information provided, this event does not appear to be device related, rather related to the patients pre-existing conditions.
 
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Brand NameTABLO HEMODIALYSIS SYSTEM
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL, INC.
1830 bering drive
san jose CA 95112 4212
Manufacturer Contact
jennifer mascioli-tudor
1830 bering drive
san jose, CA 95112-4212
6692318235
MDR Report Key8176901
MDR Text Key130781441
Report Number3010355846-2018-00002
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberPN-0000850
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/18/2018 Patient Sequence Number: 1
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