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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL INC. OUTSET MEDICAL TABLO DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OUTSET MEDICAL INC. OUTSET MEDICAL TABLO DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number TABLO
Device Problems Device Sensing Problem (2917); Improper Flow or Infusion (2954); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  Injury  
Event Description
Hemodialysis equipment malfunction / level detector self regulated adjustment / suspected sensor malfunction/ manufacture outset medical / device model tablo. Machine is designed to automatically adjust the venous level by either infusing air or pulling air from the chamber to adjust the level of this chamber. According to the manufacture they believe a sensor looking at this level is defective causing the pump to infuse air dropping this level to a lower level potentially causing excessive air into the system which would lead to patient loss of blood and delaying therapy as machine would have to be set up again and therapy restarted. Hemodialysis therapy outpatient dialysis clinic. Fda safety report id # (b)(4).
 
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Brand NameOUTSET MEDICAL TABLO
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL INC.
san jose CA 95134
MDR Report Key12883298
MDR Text Key281417770
Report NumberMW5105630
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTABLO
Device Catalogue NumberTABLO
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/26/2021 Patient Sequence Number: 1
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