MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE / FRESENIUS USA MANUFACTURING, INC. OPTIFLUX 160NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number OPTIFLUX 160 NRE

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Rash (2033)

Event Date 10/24/2023

Event Type  Injury  

Event Description

Patient arrived to facility for first dialysis treatment.Pre vs: bp 206/107, pulse 57, resp 16, temp 99.7.Treatment initiated at 07:35 on an optiflux 160nre dialyzer, as prescribed.Patient developed itching and rash on lower extremities.Benadryl 50mg ivp administered, symptoms briefly resolved and then returned.Patient became sob, solumedrol 125mg ivp and o2 @3l via n/c administered.Patient became hypotensive, ns bolus administered and treatment discontinued at 08:09.Per md, patient monitored for approx.20 minutes.Symptoms did not resolve.911 called, epinephrine 1:1000 im, benadryl 50mg po, solumedrol 125mg im administered.Patient remained alert and oriented, transferred to hospital.Vs at time of transfer: bp 153/86, pulse 94, resp 24, o2 sat 98% on 3l o2.Patient returned to facility on (b)(6) 2023 and treated on an optiflux 180nr dialyzer without incidence.Optiflux 160nre dialyzer added as allergy.

• Brand Name: OPTIFLUX 160NRE DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE / FRESENIUS USA MANUFACTURING, INC.; waltham MA 02451
• MDR Report Key: 18094185
• MDR Text Key: 327865825
• Report Number: MW5147915
• 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: 11/02/2023

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: OPTIFLUX 160 NRE
• Device Catalogue Number: 0500316E
• Device Lot Number: 23KU06037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• 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): Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 77 KG