MAUDE Adverse Event Report: NEPHROS NEPHROS; S100

Model Number	S100
Medical Device Problem Codes	Break (1069); Filtration Problem (2941)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported that a healthcare facility received a positive culture downstream of an s100 point of use (70-0280) filter on one of their sinks.There was no reported adverse event.Nephros s100 point of use is a sink water filter, class ii medical device that is placed on sink faucets in health care facilities in order to retain bacteria.The user facility routinely tests their water at their sinks and found that there was positive bacteria detected.A positive 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/follow-up report will be submitted.
Additional Manufacturer Narrative
Nephros s100 point of use is a sink water filter, class ii medical device that is placed on sink faucets in health care facilities in order to retain bacteria.The user facility routinely tests their water at their sinks and found that there was positive bacteria detected.A positive 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/follow-up report will be submitted.
Additional Manufacturer Narrative
Nephros s100 point of use is a sink water filter, class ii medical device that is placed on sink faucets in health care facilities in order to retain bacteria.The user facility routinely tests their water at their sinks and found that there was positive bacteria detected.A positive culture can be caused by improper installation, cross contamination and/or a breach of the filter membrane.Device evaluation: comprehensive review of the specific filter device history record and manufacturing inspections did not identify any product issues.The investigation of the returned filters determined that one of the internal filter components were damaged and ultimately allowed unfiltered water (with positive bacteria counts) to pass through the filter.Lot representative filter samples were tested for any signs of change in filter ability to function properly under the published product specifications.No changes or issues were identified.Active monitoring of customer plumbing systems identified pressures significantly above the product and plumbing specification.The root cause of the damage to the internal filter components was determined to be caused by excessive pressure and unusually poor water quality/conditions at the facility which stressed internal filter components above and beyond their recommended use.

• Brand Name: NEPHROS
• Common Device Name: S100
• 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: 15307007
• Report Number: 3003337893-2022-00003
• Device Sequence Number: 6484616
• Product Code: NHV
• UDI-Device Identifier: 00896241002541
• UDI-Public: (01)00896241002541(17)230428(10)PI200270
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153084
• 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): 08/26/2022

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: S100
• Device Catalogue Number: 70-0280
• Device Lot Number: PI20/0270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2020
• 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