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

Device Problem Device Alarm System (1012)

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

Event Date 02/05/2022

Event Type  malfunction  

Event Description

Tablo machine was being difficult to use.Patient started on machine #(b)(4) and then had to be transferred to machine #(b)(4).The following alarms went off during treatment with machine #(b)(4): pre-treatment: blood cassette unloaded.Pre-treatment: blood pump position error.Treatment power fail recovery: blood pump rate.Post-treatment: dialyzer connectors not ready for drain.Post-treatment: low incoming water pressure recoverable.Post-treatment: acid connector not on rinse port.Over the course of troubleshooting several internal calls were made as well as a call to outset medical resulting in a work order being placed.Starting the next treatment on this patient took in excess of 4 hours, not including the time it takes to rinse and prepare machine for next treatment.

Event Description

Tablo machine was being difficult to use.Patient started on machine and then had to be transferred to another machine.The following alarms went off during treatment with first machine listed: pre-treatment: blood cassette unloaded, pre-treatment: blood pump position error, treatment power fail recovery: blood pump rate, post-treatment: dialyzer connectors not ready for drain, post-treatment: low incoming water pressure recoverable, post-treatment: acid connector not on rinse port.Over the course of troubleshooting several internal calls were made as well as a call to outset medical resulting in a work order being placed.Starting the next treatment on this patient took in excess of 4 hours, not including the time it takes to rinse and prepare machine for next treatment.

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: 14013757
• MDR Text Key: 288603735
• Report Number: 14013757
• 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,Followup
• Report Date: 03/09/2022,03/03/2022

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: 27375 DA
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Race: Black Or African American