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

Model Number PN-0006000

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 11/02/2021

Event Type  Injury  

Event Description

Home dialysis patient dialyzing in-center on a trial basis with a new home dialysis machine.The last 10 minutes of therapy, dialysis machine alarmed due to hypotension.Rn went to check on the patient.He was unresponsive to verbal touch.100-200 ml of blood noted on floor.There appeared to be a leak at the junction of the arterial line and the dialyzer.There had not been a leak during the priming.Patient was placed in trendelenburg, blood returned to patient and 300 ml saline bolus was given.Code team was called and patient was transported to ed by ems.Electrolytes were normal.Hb was down to 9.4 mg/dl, from > 10 mg/dl earlier that month.He was kept overnight and discharged the next day.The company is investigating the defect.

• Brand Name: TABLO 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: 12810586
• MDR Text Key: 280750233
• Report Number: 12810586
• 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
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PN-0006000
• Device Catalogue Number: PN-0006000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/15/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male