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

Model Number PN-0006000

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Melted (1385)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

The outset medical engineering team reviewed the site system logs for the console at issue and verified there was no anomalous activity reflected in the logs that would have caused this event. The engineering team also performed a preliminary assessment of the console at the site and found no obvious source of cause. Additionally, extensive hardware testing has been performed since the event. Despite a thorough investigation, the testing did not reveal a root cause nor was the engineering team able to reproduce the failure under simulated conditions. As background, the tablo console is certified to the most recent iec 60601-1 3rd edition safety compliance standards. The consoles plastic enclosures have a v0 self-extinguishing rating. Further, a comprehensive dhr (device history record) review was performed. There were no non-conformances noted upon review of the dhr for the console at issue and it was confirmed that this console met all inspections and test criteria. Prior to final release and distribution to customers, all tablo consoles are inspected, tested and verified through in-process inspection and testing, followed by a quality inspection after manufacturing. Before the closure of every installation at a customer site, outset field service engineers performs a 9-point final inspection of the console. In conclusion, all of the analysis that outset has conducted to date suggests that this console was conforming to all applicable specifications.

Event Description

On (b)(6) 2021, a fire event involving a tablo console was reported. At the time of the event, the tablo console had been sitting idle in an unoccupied storage room. There was no patient involvement or reported injuries by the hospital staff as a result of this event.

• Brand Name: TABLO X 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
• Manufacturer (Section G): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• Manufacturer Contact: 6692318235
• MDR Report Key: 12425209
• MDR Text Key: 269876909
• Report Number: 3010355846-2021-00070
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PN-0006000
• Device Catalogue Number: PN-0003000
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 08/05/2021
• Event Location: No Information
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse