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

Lot Number 23HU03001

Patient Problems Apnea (1720); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/16/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, patient attended regularly scheduled in-center dialysis treatment.Pre vital signs bp-182/99, pulse-73, resp-18, temp-97.2.At approx 11:05 dialysis was initiated.At approx 11:13 patient became unresponsive, body jerking, hypotensive and apneic.Treatment ended, and blood reinfused with normal saline.911 called, patient recovered and transported to hospital via ems(emergency medical services).Post vital signs bp-150/76, pulse-60, resp.-18, temp.-97.0.Pt returned to facility (b)(6) 2023, treated on nipro cellentia 17h dialyzer without incident.Optiflux dialyzer added as allergy.

• 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: 17624433
• MDR Text Key: 322133700
• Report Number: MW5144961
• 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: 08/21/2023

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 Lot Number: 23HU03001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMBISET BLOODLINES; FRESENIUS 2008T MACHINE; GRANUFLO 2.0K 2.0CA 1.0MG 100 DEXTROSE; NATURALYTE BICARBONATE; NORMAL SALINE
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American