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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Hemorrhage/Bleeding (1888); Dizziness (2194)

Event Date 06/11/2023

Event Type  Injury  

Event Description

Patient called in to report that while treating this morning on (b)(6) 2023, blood was leaking from the arterial port connecting to the dialyzer (red).Console did not alarm did not alarm with blood leak.Patient stated there was extensive amounts of blood where the patient was forced to call 911.Paramedics stated there was 2.4 liters of blood on the ground.Patient was taken to the hospital due to dizziness and fatigue.Patient was stable at hospital.

Manufacturer Narrative

H3/h6: from the information provided, there is no indication that there was any device malfunction or nonconformance, that contributed to the reported event.Potential adverse events in the instructions for use (ifu) with the tablo system includes, but are not limited to, other, more serious, complications arising from dialysis, such as hemorrhage, air embolism, acidosis, alkalosis or hemolysis, can cause serious patient injury or death.Tablo user manual has the following warning: check all bloodlines for leaks after the treatment has started.Keep access sites uncovered and monitored.Improper bloodline connections or needle dislodgements can result in excessive blood loss, serious injury, and death.Machine alarms may not occur in every blood loss situation.Outset medical, inc.Field service engineer (fse) was dispatched to the customer home to further investigate the reported issue.The dialyzer and cartridge were discarded; therefore, root cause of the event was not able to be confirmed.Based on fse evaluation, the most likely cause was overtightening of the connection to the dialyzer.The reported blood loss amount of 2.4 liters of blood has not been verified by a healthcare professional.Follow up has been conducted.A supplemental mdr will be filed if more information is received.

Manufacturer Narrative

This supplemental report is created to correct information initially submitted for b5.Describe event or problem.On 12-jul-2023 additional information was received clarifying that patient was transported to the hospital due to acute blood loss; customer site nurse confirmed that the patient lost an estimate 300 ml - 500 ml of blood.The patient did not require transfusion and was subsequently released.

• Brand Name: TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE
• 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: lance mattoon ; 3052 orchard drive; san jose, CA 95134 ; 6692318200
• MDR Report Key: 17295365
• MDR Text Key: 318830947
• Report Number: 3010355846-2023-00083
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/11/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 06/11/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Hospitalization