NEPHROS
Received Apr 3, 2026 · Event occurred Mar 3, 2026
Report 3003337893-2026-00001 · MDR key 24781038
Device
Product problems
- Filtration Problem
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.