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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 Cardiac Arrest (1762)
Event Date 06/21/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: a mock treatment was run on the tablo unit on 25jun2019 and no issues were noted with the device. Upon follow up with the clinical staff, this event is not suspected to be caused by the device. Rather this event is most likely a result of the patient's pre-existing conditions. Production records were reviewed for the unit identified and no issues noted. Log files from the treatment were reviewed and it was confirmed that no device issues were noted.
 
Event Description
It was reported that a patient experienced a cardiac event during treatment. The patient was approximately 3 hours into a 4 hour treatment. The staff used an external defibrillator on the patient, who was conscious when transported from the clinic to the hospital. The blood was returned with no issues noted. It was not suspected that tablo contributed to the event, rather, this event was likely related to the patient's pre-existing condition.
 
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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 Key8791483
MDR Text Key151107080
Report Number3010355846-2019-00006
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 Nurse Practitioner
Type of Report Initial
Report Date 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPN-0003000
Device Catalogue NumberPN-0003000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
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: 07/15/2019 Patient Sequence Number: 1
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