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

Device Problems Energy Output Problem (1431); Unexpected Shutdown (4019)

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

Event Date 01/25/2022

Event Type  malfunction  

Event Description

Stopping the crrt run on the pt.And preparing to return the blood to the pt.And the screen turned black and an unknown alert of "unfortunately, sequoia gui has stopped" and the machine shutdown, requiring the nurse to manually return the blood to the patient.The machine was taken down to the store room.There it was plugged in and connected to the water and the output drain.The screen on the machine indicated that the company should be called for service.I called the company and notified the representative of the event.He attempted to remote in and was unable to.He was still able to run reports.He instructed me to go ahead and run a heat clean.I set the pump for a heat clean.A case number of was assigned and i was instructed to tag the machine as out of service.I then emailed all the individuals that are attending the daily tablo touchbase meetings." i was on the phone with the representative for approximately 30 minutes with the machine.This did not take into account the time it took to get the machine down to the store room, hook it up and run the heat clean.If i had not been working, the charge nurse or other staff nurse would have had to deal with this and be off the floor for an extended period of time.

Event Description

Stopping the crrt run on the pt.And preparing to return the blood to the pt.And the screen turned black and an unknown alert of "unfortunately, sequoia gui has stopped" and the machine shutdown, requiring the nurse to manually return the blood to the patient.The machine was taken down to the store room.There it was plugged in and connected to the water and the output drain.The screen on the machine indicated that the company should be called for service.I called the company and notified the representative of the event.He attempted to remote in and was unable to.He was still able to run reports.He instructed me to go ahead and run a heat clean.I set the pump for a heat clean.A case number of was assigned and i was instructed to tag the machine as out of service.I then emailed all the individuals that are attending the daily tablo touchbase meetings." i was on the phone with the representative for approximately 30 minutes with the machine.This did not take into account the time it took to get the machine down to the store room, hook it up and run the heat clean.If i had not been working, the charge nurse or other staff nurse would have had to deal with this and be off the floor for an extended period of time.

Event Description

No equipment issues or human factors interacting with equipment identified.

• Brand Name: TABLO
• 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: 14249830
• MDR Text Key: 290400881
• Report Number: 14249830
• 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,Followup,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1