Model Number DSU-H |
Device Problem
Filtration Problem (2941)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/02/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Nephros dsu-h is an in-line water filter, class ii medical device that is placed before ice machines in health care facilities in order to retain bacteria, virus and endotoxin.The user facility routinely test their water at their ice machine and found that there was positive bacteria detected.A positive culture can be caused by an improper disinfection of the ice machine or water lines leading to the ice machine, and/or a breach of the filter membrane.The root cause of the positive culture could not be confirmed as the filter was not returned for additional investigation.Comprehensive review of the specific filter device history record and manufacturing inspections did not identify any product issues.Additional information including culture results and return of the device are needed to fully investigate the event.If additional information is received, a supplemental/follow-up report will be submitted.This mdr was reported late as nephros is awaiting esg account setup/verification.
|
|
Event Description
|
On (b)(6) 2022 it was reported that a healthcare facility received a positive culture downstream of a dsu-h (70-0285) in one of their ice machines.There were no reported adverse events.Nephros dsu-h is an in-line water filter, class ii medical device that is placed before ice machines in health care facilities in order to retain bacteria, virus and endotoxin.The user facility routinely test their water at their ice machine and found that there was positive bacteria detected.A positive culture can be caused by an improper disinfection of the ice machine or water lines leading to the ice machine, and/or a breach of the filter membrane.The root cause of the positive culture could not be confirmed as the filter was not returned for additional investigation.Comprehensive review of the specific filter device history record and manufacturing inspections did not identify any product issues.Additional information including culture results and return of the device are needed to fully investigate the event.If additional information is received, a supplemental/follow-up report will be submitted.
|
|
Search Alerts/Recalls
|
|