MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS OPTIFLUX 180NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500318E

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Nausea (1970); Vomiting (2144); Hot Flashes/Flushes (2153)

Event Date 08/28/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, patient attended regularly scheduled in-center dialysis treatment.Pre vital signs bp-163/88, pulse-84, resp-16, temp-97.5.Treatment started with use of f180 nre dialyzer as prescribed.Within minutes of starting dialysis treatment, patient complained of nausea, vomiting, diarrhea, abdominal pain, chest tightness and flushing.Treatment was discontinued, ondansetron 4mg iv push and diphenhydramine 50 mg iv push was administered.Patient recovered on site and was discharged to home stable.Patient returned to clinic on (b)(6) 2023, treated on a f180 nr dialyzer without incident.F180 nre dialyzer added as an allergy.Notable data: patient had a similar episode in the hospital on (b)(6) 2023.

• Brand Name: FRESENIUS OPTIFLUX 180NRE DIALYZER
• 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: 17711945
• MDR Text Key: 323090299
• Report Number: MW5145376
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Lot Number: 23JU07018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMBISET BLOODLINES.; FRESENIUS 2008T MACHINE.; GRANUFLO 2.0K 2.5CA 1.0MG 100 DEXTROSE.; NATURALYTE BICARBONATE.; NORMAL SALINE.
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White