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

Device Problems Alarm Not Visible (1022); Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/27/2022

Event Type  malfunction  

Event Description

The rn accessed the patient's vascath and began a 4 hour hemodialysis (hd) run.40 minutes later the patient's machine began alarming high venous pressure.The rn checked the vascath and dialysis line for kinks/clamps and resumed the treatment.Persistent alarms required blood to be returned to avoid clotting in the lines.Blood was returned; however, during the blood return process the rn and charge rn noticed that the saline bag had run completely dry without the machine alarming.Large amounts of air and bubbles were noticed to be circulating in the circuit.No bubbles/air appeared to be entering the blood return line or entering the patient.The cartridge and dialyzer were replaced, and the tablo run was resumed.The rest of the 4 hour hd run ran smoothly up until when the patient had about 40 minutes left.The high venous pressure alarm continued to alarm.A manual flush of 100ml was performed with no improvement in the venous pressure.At this time the transmembrane pressure was also rising to 40-50, when the patient's baseline was around 2-3.At this point, tablo had removed around 2300ml from the patient and treatment was ended early.According to the manufacture instructions "tablo keeps track of the amount of saline needed to complete the prime discard and will alert the user to change the saline bag if there is not enough left to complete this step".In the case above the user should have been prompted to change the saline bag prior to beginning the blood return process.

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: 14013756
• MDR Text Key: 288604258
• Report Number: 14013756
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: White