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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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OUTSET MEDICAL, INC. TABLO HEMODIALYSIS SYSTEM HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number PN-0003000
Device Problem Use of Device Problem (1670)
Patient Problem Blood Loss (2597)
Event Date 05/18/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: log files of the device were reviewed by outset medical personnel. A device issue related to a blood leak sensor component failure was identified; however, was not the reason for the adverse event. The nurse had attempted a manual blood return; however, it was unsuccessful due to user error. The event of blood loss is attributed to this user error.
 
Event Description
It was reported that an end treatment alarm was observed. The patient experienced a blood loss of approximately 440 ml (300 ml in dialyzer and 140 ml in cartridge). Upon further review, it was determined that the nurse had not completed the manual blood return correctly. Therefore, this event is not device related, rather attributed to user error.
 
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Brand NameTABLO HEMODIALYSIS SYSTEM
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS 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
jennifer mascioli-tudor
1830 bering drive
san jose, CA 95112-4212
6692318235
MDR Report Key8688739
MDR Text Key147649919
Report Number3010355846-2019-00005
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 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
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?
Event Location No Information
Date Manufacturer Received05/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2018
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: 06/11/2019 Patient Sequence Number: 1
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