MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA F180NR OPTIFLUX ADVANCED FRESENIUS POLYSULFONE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number (10)22BU02008

Device Problems Crack (1135); Fluid/Blood Leak (1250); Pressure Problem (3012)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/18/2022

Event Type  Injury  

Event Description

While receiving dialysis utilizing tablo machine, was noted that the optiflux filter cracked due to the clotting of patient's blood, causing back pressure and leakage.Fda safety report id# (b)(4).

• Brand Name: F180NR OPTIFLUX ADVANCED FRESENIUS POLYSULFONE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; waltham MA 02451
• MDR Report Key: 14621290
• MDR Text Key: 293562812
• Report Number: MW5110126
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: (01)00840861100156
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2022

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 Operator: Health Professional
• Device Model Number: (10)22BU02008
• Device Lot Number: 22BU02008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White