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

Model Number PN-0006000

Device Problems Device Emits Odor (1425); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 12/11/2021

Event Type  malfunction  

Event Description

Patient was undergoing hemodialysis when the tablo had a water module failure.The tablo instructed the user to rinse the patient back, which was done.The module was changed out, and the failure occurred again.The user called tablo.Tablo attempted to remotely troubleshoot.While this was occurring, the user smelled smoke.The device was disconnected and shut off.Another tablo was obtained, and the patient's hemodialysis was completed without further incident.No untoward patient effects.Manufacturer response for dialyzer, high permeability with or without sealed dialysate system, tablo(r) hemodialysis system (per site reporter).Outset medical came to facility to evaluate the tablo.

• Brand Name: TABLO(R) 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: 13051595
• MDR Text Key: 282557213
• Report Number: 13051595
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PN-0006000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33215 DA
• Patient Sex: Male