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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 PN-0003000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 11/23/2020
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. 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. Field service engineer (fse) reviewed site system logs with a procedure date of (b)(6) 2020, and verified that there was no issue with the system which caused the patient event. The console is operating as intended after the event. A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product.
 
Event Description
It was reported that a covid-19 positive patient who was vented and sedated, triggered multiple air in venous bloodline alarms during a three consecutive day dialysis treatment on tablo. It was reported that the patient was vascularly dry, clotting, and his vein was collapsing around the catheter. Despite these problems, the clinical personnel kept putting the patient back on tablo; consequently, the patient's cumulative blood loss was estimated to be 800 ml. Per the information received from the customer site, it is not believed that the device contributed to the patient event.
 
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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.
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 Key11047396
MDR Text Key223390411
Report Number3010355846-2020-00036
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00850001011112
UDI-Public(01)00850001011112(11)181016
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 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/23/2020
Event Location No Information
Date Manufacturer Received11/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2018
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: 12/21/2020 Patient Sequence Number: 1
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