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

Device Problems Obstruction of Flow (2423); Pressure Problem (3012); Protective Measures Problem (3015)

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

Event Date 02/11/2022

Event Type  malfunction  

Event Description

Pt was on tablo with 5 hours remaining when nurse got high arterial pressure alarms.Nurse noticed that the arterial line attached to tablo was filled with clots.Transmembrane pressures within the 90s.Blood returned and when attempting to drain the dialyzer, machine kept alarming to unclamp the yellow clamp.The clamp was open and the tablo help line was contacted.Nurse was unable to get a hold of anyone and was told to leave a message.Site tablo representative was called directly and instructed to turn off and power back on machine and try again.This resolved the issue.Later when the run was completed and tablo was disconnected the machine gave a message to call technical support.Before nurse could call, the message disappeared, and a heat cycle was completed.The alarm: saline clamp medium did not happen until after a new saline bag was required and changed out.10 minutes later the machine started alarming saline clamp medium.It is unknown what potential harm there is when powering off a machine that is connected to the patient.

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: 14013680
• MDR Text Key: 288604739
• Report Number: 14013680
• 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 Age: 24455 DA
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic