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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO X HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OUTSET MEDICAL, INC. TABLO X HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PN-0003000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 03/18/2021
Event Type  Injury  
Manufacturer Narrative
From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. Potential adverse events in the instructions for use (ifu) with the tablo system includes, but are not limited to, other, more serious, complications arising from dialysis, such as hemorrhage, air embolism, acidosis, alkalosis or hemolysis, can cause serious patient injury or death. Outset medical, inc. Technical team has reviewed site system logs with a procedure date of (b)(6) 2021, and verified that there was no issue with the system which caused the patient event. The device is functioning post treatment. A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product event.
 
Event Description
It was reported that a patient who was covid-19 positive coded during a dialysis treatment. It was reported that the patient was previously dialyzed twice due to high potassium and catheter not being operable. During the first treatment setup, machine was treating but due to catheter issues the treatment was ended and care personnel conducted a new catheter placement. Approximately 44 minutes into a second treatment setup, the patient showed continued decline in blood pressure, then progressed into bradycardia and asystole. Code blue was called, blood was returned and protocols were followed, including cardiopulmonary resuscitation (cpr) and medications. Treatment was not resumed because patient remained too unstable for dialysis treatment. Based on the information provided, the clinical staff does not believe that the tablo device caused the event rather this event was attributed to the patient's pre-existing conditions.
 
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Brand NameTABLO X 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
Manufacturer (Section G)
OUTSET MEDICAL, INC.
3052 orchard drive
san jose CA 95134
Manufacturer Contact
6692318235
MDR Report Key11669708
MDR Text Key245630159
Report Number3010355846-2021-00067
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190793
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 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
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? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/18/2021
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2020
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: 04/15/2021 Patient Sequence Number: 1
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