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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/13/2022

Event Type  malfunction  

Event Description

Tablo run started in evening, about 30 minutes later first alarm went off stating bypass valve failure and instructed us to press and release the power button to restart.After following those instructions new alarm of "bad dialysate conductivity" appeared and instructed us that the treatment must end and the blood to be discarded and to not manually return the blood.Following tear down a third alarm appeared on the screen that tablo requires technical support and to call outset technical support called outset technical support.She recommended switching out the machine as she couldn't see anything on her end that would result in the alarms.She also estimated the patient blood loss to 122ml will review tablo team meeting.

Event Description

No equipment issues or human factors interacting with equipment identified.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• 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: 14250011
• MDR Text Key: 290389805
• Report Number: 14250011
• 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
• Report Date: 04/19/2022

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: 04/19/2022
• 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
• Patient Age: 17520 DA
• Patient Sex: Male
• Patient Weight: 84 KG