MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX F160; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 17LU06023

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2018

Event Type  malfunction  

Event Description

At the end of patient treatment, during blood return, blood was leaking out of top of dialyzer on dialysis machine.Machine saying "low flow error".Unable to clean blood out of hanson's blue and red lines after several attempts.Machine removed from service.Call placed to fresenius to come and service machine.Fresenius filled out a complaint against dialyzer optiflux f160.

• Brand Name: OPTIFLUX F160
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 920 winter street; waltham MA 02451
• MDR Report Key: 7288588
• MDR Text Key: 100676092
• Report Number: 7288588
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 17LU06023
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DIALYSIS.; FRESENIUS DIALYSIS MACHINE 333 ((B)(4))
• Patient Age: 53 YR