Model Number S100 |
Device Problems
Break (1069); Filtration Problem (2941)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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