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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO(R) CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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OUTSET MEDICAL, INC. TABLO(R) CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number PN-0008544
Patient Problem Insufficient Information (4580)
Event Date 03/11/2024
Event Type  malfunction  
Event Description
Rn1 and tech started treatment within two minutes there was alarm that stated "air in blue line" x4 times.3 x10 ml syringe used to draw back bubbles with 1x 20ml to remove bubbles which was unsuccess and then used the hand crank to increase the blood in the chamber, that is when the blood leak was noted on the arterial line connects at the v.Returned blood with success and then reset up machine.Manufacturer response for set, tubing, blood, with and without anti-regurgitation valve, tablo(r) cartridge (per site reporter).Outset medical has been notified in the past of this issue and they don't usually respond or they delay investigation.User facility has had multiple reports on this item in the last two years with no resolve.
 
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Brand Name
TABLO(R) CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
OUTSET MEDICAL, INC.
3052 orchard drive
san jose CA 95134
MDR Report Key18939968
MDR Text Key338121994
Report Number18939968
Device Sequence Number1
Product Code FJK
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 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPN-0008544
Device Catalogue NumberPN-0004220
Device Lot NumberM23166L02S01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/13/2024
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/20/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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