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

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 02/13/2022

Event Type  malfunction  

Event Description

Tablo had been restarted as scheduled following a heat cycle.One hour later rns noted leaking from red port of tablo dialyzer, the machine did not alarm, connection was slightly loose, but we were unable to restart the machine, so the cartridge and dialyzer were changed.Tablo should alarm when the system is leaking.

Event Description

No equipment issues or human factors interacting with equipment identified.

• 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: 14013726
• MDR Text Key: 288604682
• Report Number: 14013726
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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: 03/09/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24455 DA
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic