MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO(R) CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number PN-0008544

Patient Problem Insufficient Information (4580)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

Caregiver was setting up a dialysis machine for a treatment and noticed saline leaking from the cartridge.She stopped the setup and ejected the cartridge.When she pulled it out to inspect it, she saw that the blood line was not seated properly in the connector that hooks the blood tubing to the section that connects the soft tubing that goes around the blood pump.The cartridge was saved so the outset representative could be shown where the problem was coming from.This is on a tablo dialysis cartridge pn-0004220, lot #m23156l03s01, expiration date 12/31/24.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.

• 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 Key: 18940012
• MDR Text Key: 338122823
• Report Number: 18940012
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PN-0008544
• Device Catalogue Number: PN-0004220
• Device Lot Number: M23156L03S01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1