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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 05/29/2020
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, clotting may be evidenced by high venous pressure, dark blood in lines or drip chambers, visible clots in the drip chamber or dialyzer. Failure to respond to clotting may expose the blood circuit to sustained high pressures leading to a possible blood leak or hemolysis (blood cell damage). Outset medical inc. Field service engineer (fse) was dispatched to the customer site to further investigate the reported issue. The reported issue was not reproduced during field evaluation, and unit was deemed operable. 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 with vessel stenosis and a permanent catheter experienced loss of consciousness three hours into treatment, treatment was ended. During treatment there was increase in venous pressure that could not be overcome, and nurse was unable to move past the high venous pressure; subsequently, patient loss approximately 200 cc of blood due to possible clotting. The nurse administered approximately 500 cc fluid bolus through the arterial catheter port as the venous catheter port was very difficult to flush or aspirate. It was noted that the nurse did not flush the system at any time before to attempt to visualize the dialyzer or venous drip chamber (vdc). The patient recovered and is stable. Additional information was received from outset medical inc. Clinical manager on 6/18/2020, which indicated that the site dialysis director presumes the patient simply clotted and the event was not attributed to a product malfunction.
 
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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 Key10189009
MDR Text Key201060674
Report Number3010355846-2020-00021
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 06/24/2020
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 Received05/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2019
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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