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

Lot Number 20M248

Device Problems Loss of Power (1475); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2021

Event Type  malfunction  

Event Description

Patients tablo dialysis machine alarmed that there was air in the system within the first 60 minutes of treatment.All connections tight, no cracks noted to cause air in the system.This resulted in the machine shutting down.Device was discarded.The first incident occurred with machine #4, where the patient¿s machine alarmed that there was air in the system within the first 60 minutes of treatment.The nurse was unable to rinse back patient¿s blood and had to set up a new system.At this time, the nurse inspected the set up and all connections were tight, could not locate any cracks on any part of the set up to cause air in the system so it was discarded (although a picture was taken of the system).This was then reported to tablo and the machine was looked at by their biomed and was reported okay to put back in rotation.It was also discussed in depth with our tablo program specialist.This cartridge did not leak at all that we noticed, but air got into it somehow that we are still unsure of the reason as her treatment was able to run for an hour without any issues.We are now wondering if there could have been a ¿slow leak¿ somewhere (maybe the pressure pod) that air got in and over time built up enough in the cartridge that triggered the alarm.

• Brand Name: TABLO 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: 11974228
• MDR Text Key: 255366328
• Report Number: 11974228
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 20M248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/10/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1