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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2024
Event Type  malfunction  
Event Description
Last week and this morning, my technicians came to me to report defective tablo cartridges.The leaks both appear to be coming from the connection from the hard plastic coupler that attaches to the soft tubing that wraps around the blood pump, to the rest of the tubing.This is the same area as the blood leaking from the cartridge that was reported earlier this year.The lot number in that case was m23137l02s01.On the second instance, the lot number was m23156l03s01.Manufacturer response for set, tubing, blood, with and without anti-regurgitation valve, tablo(r) cartridge (per site reporter).No response yet.
 
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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 Key18948582
MDR Text Key338225593
Report Number18948582
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 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPN-0008544
Device Catalogue NumberPN-0004220
Device Lot NumberM23156L03S01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2024
Event Location Hospital
Date Report to Manufacturer03/21/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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