MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO SINGLE USE CARTRIDGE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Protective Measures Problem (3015); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Dialysis rn (registered nurse) began an intermittent hemodialysis treatment on patient with the tablo dialysis machine.Approximately 1 hour into the treatment, the machine issues an error that read "shutdown error.Data transmission error.Please restart the program.1.Press and release the power button on the back of the touchscreen.Wait for the screen to go black.Press again to restart." the rn followed the instructions.The screen then went black, so rn began a manual return of the blood to the patient.While returning the blood, the tablo cartridge began to leak blood from locations that should be sealed, such as the needleless port and the pressure pad.The cartridge also began to pull air into the line.At this point, rn stopped the blood return for the safety of the patient.When she removed the cartridge, it was noted that the pressure pad had come apart in the machine and blood was noted in many of the access points on the machine.Tablos pulled from use on patients, called the vendor, bagged the cartridge to give to the vendor.Tablo update - user error: when returning blood to the patient, the handle should be turned clockwise.The dialysis rn turned it counterclockwise.Blood filled the cartridge causing it to explode.We were told the "shutdown error" message was a software error that has been corrected.

• Brand Name: TABLO SINGLE USE CARTRIDGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• MDR Report Key: 15592524
• MDR Text Key: 301630324
• Report Number: 15592524
• Device Sequence Number: 1
• Product Code: KDI
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male