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U.S. Department of Health and Human Services

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

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OUTSET MEDICAL, INC. TABLO DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NameTABLO
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OUTSET MEDICAL, INC.
3052 orchard drive
san jose CA 95134
MDR Report Key14249830
MDR Text Key290400881
Report Number14249830
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/22/2022
Event Location Hospital
Date Report to Manufacturer04/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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