MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA RTG F180NRE OPTIFLUX DIALYZER

Model Number F180NRE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Arrest (1762)

Event Date 10/10/2020

Event Type  Death  

Event Description

Hemodialysis pt attended regularly scheduled dialysis treatment.Pre vs 166/66, pulse 88, temp 98.5.At approx 1246 dialysis initiated.At approx 1355 pt blood lines began clotting.Hd tx interrupted.Patient's fistula needles were disconnected from both venous and arterial bloodlines.Both fistula needles were flushed and remained patent.A new dialysis system including both the combiset lines and f180nre optiflux dialyzer was to be set up and primed.Upon re-initiation of dialysis treatment, the venous line was reconnected to the venous needle and the arterial line was reconnected to the arterial needle.Hemodialysis treatment was re-initiated and blood pump was turned on.Within approx 2 minutes the patient reported pain at the venous needle site and then became unresponsive.Cpr and 911 was initiated.Ems arrived and took over care of the patient.Patient was transferred to hospital via ems.Subsequent inspection of dialysis lines, the venous line and dialyzer was noted to have visible air and no saline within the lines.The arterial line was noted to have visible saline present.The patient expired on (b)(6) 2020.

• Brand Name: F180NRE OPTIFLUX DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA RTG; waltham MA
• MDR Report Key: 10801115
• MDR Text Key: 215249512
• Report Number: 10801115
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: F180NRE
• Device Lot Number: 20HU07025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2020
• Distributor Facility Aware Date: 10/10/2020
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 10/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 57 YR
• Patient Weight: 99