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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-0006000
Device Problem Fluid Leak (1250)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
Event Date 11/02/2021
Event Type  Injury  
Event Description
Home dialysis patient dialyzing in-center on a trial basis with a new home dialysis machine. The last 10 minutes of therapy, dialysis machine alarmed due to hypotension. Rn went to check on the patient. He was unresponsive to verbal touch. 100-200 ml of blood noted on floor. There appeared to be a leak at the junction of the arterial line and the dialyzer. There had not been a leak during the priming. Patient was placed in trendelenburg, blood returned to patient and 300 ml saline bolus was given. Code team was called and patient was transported to ed by ems. Electrolytes were normal. Hb was down to 9. 4 mg/dl, from > 10 mg/dl earlier that month. He was kept overnight and discharged the next day. The company is investigating the defect.
 
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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
MDR Report Key12810586
MDR Text Key280750233
Report Number12810586
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPN-0006000
Device Catalogue NumberPN-0006000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/15/2021 Patient Sequence Number: 1
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