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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
Model Number PN-0003000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/21/2019
Event Type  Death  
Manufacturer Narrative
Communications with nursing staff indicated that the patient was very sick and the event was not related to dialysis product or treatment. The device was not returned to manufacturer; however, was evaluated at the user facility and functioned as expected. An investigation of the device history record was conducted and found no deviations or nonconformances noted during the manufacturing process.
 
Event Description
It was reported that the patient coded 54 minutes post dialysis treatment and passed away. The hospital staff is not attributing the death of the patient to the dialysis treatment. The treatment had proceeded as normal. The patient was very sick and the clinical staff does not believe that tablo or dialysis caused this event. There were no complaints or symptoms exhibited from the patient during the treatment. There was no problem with the machine or supplies noted. There was no blood loss or leaks noted during the treatment.
 
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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 (Section G)
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 Key8688375
MDR Text Key147638020
Report Number3010355846-2019-00002
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberPN-0003000
Device Catalogue NumberPN-0003000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2018
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: 06/11/2019 Patient Sequence Number: 1
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