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

Model Number PN-0006310

Patient Problem Insufficient Information (4580)

Event Date 12/13/2023

Event Type  malfunction  

Event Description

Towards the end of dialysis, noted that normal saline is leaking through the blood circuit, approximately 1000ml infused.Tablo notified and said it's possibly a cartridge issue.Manufacturer response for dialysis cartridge, tablo cartridge (per site reporter), will review.

• 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: 18475075
• MDR Text Key: 332437813
• Report Number: 18475075
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN-0006310
• Device Catalogue Number: PN-0004220
• Device Lot Number: M23130L02S01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Male
• Patient Ethnicity: Hispanic