OPTIFLUX 180NRE DIALYZER FINISHED ASSY

DIALYZER

This device is manufactured by FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING.

The following problems were reported about this device:

Year Description Events/year Type
2024 Low Blood Pressure/ Hypotension 1 Patient
2024 Itching Sensation 1 Patient
2024 Hypersensitivity/Allergic reaction 2 Patient
2024 High Blood Pressure/ Hypertension 1 Patient
2024 Hemorrhage/Blood Loss/Bleeding 63 Patient
2024 Dyspnea 3 Patient
2024 Anxiety 1 Patient
2024 Fluid/Blood Leak 49 Device
2024 Adverse Event Without Identified Device or Use Problem 1 Device
2023 Urticaria 1 Patient
2023 Muscle Weakness/Atrophy 1 Patient
2023 Hypersensitivity/Allergic reaction 1 Patient
2023 Hemorrhage/Blood Loss/Bleeding 63 Patient
2023 Fatigue 1 Patient
2023 Fluid/Blood Leak 97 Device
2023 Adverse Event Without Identified Device or Use Problem 1 Device
2022 Hemorrhage/Blood Loss/Bleeding 1 Patient
2022 Fluid/Blood Leak 65 Device
2022 Adverse Event Without Identified Device or Use Problem 3 Device