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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 03/08/2024
Event Type  malfunction  
Event Description
Tablo dialysis cartridge starting leaking after the blood started going through the cartridge.It leaked down the front of the machine and onto the floor.We have had several of these leaks from the tablo dialysis cartridges lately.They are leaking from the hard plastic connector that connects the soft blood pump tubing to the rest of the circuit.The lot number on this cartridge was m23166l03s01.Expiration date is 12/31/24.We were unable to return the blood to the patient due to risk of contamination.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 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 Key18939912
MDR Text Key338116965
Report Number18939912
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 NumberM23166L03S01
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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