MAUDE Adverse Event Report: NEPHROS NEPHROS; DSU-H

Model Number	DSU-H
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: NEPHROS
• Common Device Name: DSU-H
• 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: 14601899
• Report Number: 3003337893-2022-00001
• Device Sequence Number: 4794239
• Product Code: NHV
• UDI-Device Identifier: 00896241002343
• UDI-Public: (01)00896241002343(17)240628(10)PI210386
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141731
• 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
• Report Date (Section B): 05/25/2022

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 Expiration Date: 06/24/2024
• Device Model Number: DSU-H
• Device Catalogue Number: 70-0285
• Device Lot Number: PI21/0386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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