MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO OPTIFLUX 160NRE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PN-0006000

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Red securement on the top of the dialyzer loose causing approx.Blood loss of 200ml on the floor.Machine did not alarm.Device secured.Issues called in to tablo help line.Case #(b)(4).Machine removed from service.Currently remains out of service at this time, as of 5/4.

• Brand Name: TABLO OPTIFLUX 160NRE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.
• MDR Report Key: 16903197
• MDR Text Key: 315029920
• Report Number: MW5117422
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/05/2023

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-0006000
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2023
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 141 KG