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

Model Number 70-0285

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2017

Event Type  malfunction  

Event 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
• Type of Device: SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U
• Manufacturer (Section D): NEPHROS, INC.; 41 grand ave; river edge NJ 07661
• Manufacturer (Section G): NEPHROS, INC.; 41 grand ave.; river edge NJ 07661
• Manufacturer Contact: hollie johnson ; 41 grand ave; river edge, NJ 07661 ; 7324034681
• MDR Report Key: 7112518
• MDR Text Key: 95769046
• Report Number: 3003337893-2017-00001
• Device Sequence Number: 1
• Product Code: NHV
• UDI-Device Identifier: 00896241002343
• UDI-Public: 01008962410023431718092810PI150360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 5090885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2017
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1