MAUDE Adverse Event Report: NEPHROS, INC. DSU-D; SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U

Model Number	70-0285
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Nephros received a report from a user facility advising us that one of their ice machines tested positive with an unspecified species of bacteria.There were no reported adverse events or health issues connected with the positive result.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 tests their water at the ice machine and found that there was positive bacteria detected.

• Brand Name: DSU-D
• Common Device Name: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U
• Manufacturer (Section D): NEPHROS, INC.; 41 grand ave; river edge NJ 07661
• MDR Report Key: 7112518
• Report Number: 3003337893-2017-00001
• Device Sequence Number: 16413964
• Product Code: NHV
• UDI-Device Identifier: 00896241002343
• UDI-Public: 01008962410023431718092810PI150360
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: 5090885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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: Biomedical Engineer
• Device Expiration Date: 09/28/2018
• Device Model Number: 70-0285
• Device Lot Number: PI15/0360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2017
• Device Age: 2 YR
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1