MAUDE Adverse Event Report: NEPHROS NEPHROS; SSU-D

Model Number	SSU-D
Medical Device Problem Codes	Filtration Problem (2941); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026 it was reported that a healthcare facility received a positive endotoxin culture downstream of an ssu-d (70-0243d) filter on one of their ro machines and observed the device had deformed.There was no reported adverse event.The nephros ssu-d is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices.It assists in providing hemodialysis quality water or bicarbonate concentrate.The device is not a complete water treatment system but serves to remove biological contaminants.Therefore, it must be used in conjunction with other water treatment equipment (ro, di, etc.).The user facility routinely tests their water to ensure the removal of endotoxins.A positive endotoxin culture can be caused by improper installation, cross contamination and/or a breach of the filter membrane.Comprehensive review of the specific filter device history record and manufacturing inspections did not identify any product issues and the investigation is underway to determine the root cause.Once the investigation is completed, a supplemental/followup report will be submitted.
Additional Manufacturer Narrative
The nephros ssu-d is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices.It assists in providing hemodialysis quality water or bicarbonate concentrate.The device is not a complete water treatment system, but serves to remove biological contaminants.Therefore it must be used in conjunction with other water treatment equipment (ro, di, etc.).The user facility routinely tests their water to ensure the removal of endotoxins.A positive endotoxin culture can be caused by improper installation, cross contamination and/or a breach of the filter membrane.Comprehensive review of the specific filter device history record and manufacturing inspections did not identify any product issues and the investigation is underway to determine the root cause.Once the investigation is completed, a supplemental/followup report will be submitted.

• Brand Name: NEPHROS
• Common Device Name: SSU-D
• Manufacturer (Section D): NEPHROS; 380 lackawanna place; south orange NJ 07079
• Manufacturer Contact: vashone thomas ; 380 lackawanna place; south orange, NJ 07079 ; 2013450829
• MDR Report Key: 24781038
• Report Number: 3003337893-2026-00001
• Device Sequence Number: 12295772
• Product Code: FIP
• UDI-Device Identifier: 20896241002224
• UDI-Public: (01)20896241002224(17)280928(10)PI250759
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: SSU-D
• Device Catalogue Number: 70-0243D
• Device Lot Number: PI25/0759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown