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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 Problems Embolus (1830); Blood Loss (2597)
Event Date 01/11/2020
Event Type  Injury  
Manufacturer Narrative
Console was tested pre-treatment as part of set up and no issues were noted.The facility investigation concluded that issues observed were related to the catheter placement and patient anatomy and not device related.The tablo device performed as intended.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 the patient clotted off while undergoing treatment on tablo four times over a three-day period.Blood loss was estimated to be 1 liter total.Treatments were ended each time due to air getting into the arterial line.Later investigation by hospital management revealed that this was due to poor catheter placement and patient anatomy challenges.The nephrologist intentionally chose to retry treatment each time instead of fixing the catheter.The patient condition is stable / improving, and the patient is tolerating continued dialysis.It was concluded that the tablo device performed as intended.
 
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Brand Name
TABLO HEMODIALYSIS SYSTEM
Type of Device
DIALYZER, 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 Key9690887
MDR Text Key178529925
Report Number3010355846-2020-00013
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00852221011112
UDI-Public(01)00852221011112(11)181017
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 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPN-0003000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/13/2020
Initial Date FDA Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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