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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
Model Number TABLO X HEMODIALYSIS SYSTEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of consciousness (2418); Loss Of Pulse (2562)
Event Date 05/26/2020
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. 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 about one hour into treatment, the patient became hypotensive and coded. Treatment had to be terminated. There was no blood loss. Treatment was not resumed as the patient needed cardiopulmonary resuscitation (cpr) and other medical attention. Patient did survive the occurrence. This patient was a new start and the nephrologist was not sure how the patient would tolerate the dialysis treatment. The clinician ruled the tablo device out as the cause for the event. The unit operated as intended.
 
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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.
1830 bering drive
san jose CA 95112 4212
Manufacturer (Section G)
OUTSET MEDICAL, INC.
1830 bering drive
san jose CA 95112 4212
Manufacturer Contact
6692318235
MDR Report Key10189587
MDR Text Key201022466
Report Number3010355846-2020-00020
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 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTABLO X HEMODIALYSIS SYSTEM
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 Received05/26/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/12/2019
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: 06/24/2020 Patient Sequence Number: 1
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