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

Device Problems Loose or Intermittent Connection (1371); Product Quality Problem (1506); Pressure Problem (3012); Air/Gas in Device (4062)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/06/2022

Event Description

Reporter called to report on hemodialysis machine that is being used in his facility called tablo made by outset medical.Reporter states while working in the dialysis unit in the hospital, he states the new tablo hemodialysis machines have only been functioning 15% of the time.There are issues with the circuit and have to be changed 8-10 in 24hrs.The access has negative pressure which would cause no return of blood and fluids.The filter screw fitting is loose and sucks 5-10% of air.There are about 11 hemodialysis machines and all of them have malfunctioned while being used on patients.Patients have received blood transfusion due to malfunctioning of the device.

• Brand Name: TABLO HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.
• MDR Report Key: 15798785
• MDR Text Key: 303726356
• Report Number: MW5113235
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/12/2022
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR