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

Model Number PN-0003001

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2022

Event Type  malfunction  

Event Description

The machine alarmed "water pressure error" during the treatment.Blood was returned to the patient and machine was changed to another machine.Due to machine issues, we were not able to follow prescribed treatment time.Nephrologist was informed.Patient's daughter was also informed.

• Brand Name: TABLO(R) HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.
• MDR Report Key: 15923446
• MDR Text Key: 304899350
• Report Number: 15923446
• 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: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PN-0003001
• Device Catalogue Number: PN-0003001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Male
• Patient Weight: 110 KG